Device, system and method for treating obesity

ABSTRACT

An obesity treatment device is provided, the device comprising: at least one operable stretching device implantable in an obese patient and adapted to stretch a portion of the patient&#39;s stomach wall and an operation device for operating the stretching device when implanted to stretch the stomach wall portion such that satiety is created.

This application is a continuation of U.S. patent application Ser. No.12/865,044, filed Jul. 28, 2010, and issued as U.S. Pat. No. 10,653,542,which is the U.S. National Phase of International Application No.PCT/SE2009/000042, filed Jan. 29, 2009, which designated the U.S. andclaims priority of Swedish Application No. 0802138-8, filed Oct. 10,2008, and claims the benefit of U.S. Provisional Application No.61/006,719, filed Jan. 29, 2008, the entire contents of each of whichare hereby incorporated by reference.

TECHNICAL FIELD

The present invention relates to a device, a system, and a method fortreating obesity.

BACKGROUND

In the past, obese patients have been treated by gastric reductionsurgery to restrict the food intake of the patient. At present, twogastric restriction procedures for treating obesity are most commonlyperformed, namely Adjustable Gastric Banding (AGB) and Vertical BandedGastroplasty (VBG).

In AGB, a constricting band is placed completely around an obesepatient's surgically intact stomach near the upper end thereof, justbelow the junction of stomach and esophagus, to restrict the food intakeof the patient. As the band constricts the stomach, a small gastricpouch is formed above the band and a reduced permanent stoma in thestomach. The idea being that a small amount of food filling the smallpouch causes the patient to sense fullness, i.e., satiety. Examples ofAGB are disclosed in U.S. Pat. No. 4,592,339 and European Patent No.0611561,

In VBG, typically the stomach is stapled vertically with four rows oflinear staples, which compartmentalize the stomach into an elongateproximal smaller compartment adjacent the esophagus and a distal largercompartment, so that the volume of the smaller compartment is about 10%of the volume of the stomach. A circular hole is punched-out in thestomach at the lower end of the rows of linear staples and severalcircular rows of staples are placed on the stomach around the circularhole. A band is placed through the circular hole and is secured aroundthe stomach, whereby the band defines a narrow outlet opening from thesmaller compartment into the larger compartment of the stomach. Oncesecured, the band prevents the stomach from stretching at the outletopening, which results in that the outlet opening over time maintainsits initial small diameter. Food that the patient takes in is held up inthe smaller compartment causing the sensation of fullness. Then, thefood empties slowly through the outlet opening into the largercompartment where digestion takes place normally. Examples of VBG aredisclosed in U.S. Pat. Nos. 5,345,949 and 5,549,621.

There are few complications associated with AGB and VBG. However, it isimportant that the patient very carefully chews food completely beforeswallowing it, so that food pieces collected in the smaller compartmentof the stomach are able to pass through the narrow outlet opening of thesmaller compartment. If food pieces were stuck in the outlet opening itmight cause the patient to vomit and feel sick. In such a case thepatient should have to visit a doctor or nurse. Another complicationassociated with AGB and VBG is that the patient may suffer from acidstomach reflux at night.

The use of electrical stimulation of the stomach wall to cause thepatient to feel satiety has also been used.

SUMMARY

It is an object to overcome the complications associated with existinggastric reduction surgery for treating obesity, i.e., AGB and VBG.

It is another object to provide a new device for treating obesity.

These objects and others are obtained by device described in theappended claims. Thus, by providing a device that comprises at least oneoperable stretching device implantable in an obese patient and adaptedto stretch a portion of the patient's stomach wall, and an operationdevice for operating the stretching device when implanted to stretch thestomach wall portion such that satiety is created, a device for treatingobesity is obtained. The present invention is based on the realizationthat by creating a stretching effect of the stomach wall a feeling ofsatiety is created. As a result, there is no need for providing areduced permanent stoma in the stomach as required by AGB and VBG. Thus,the complications associated with such a reduced stoma are eliminated bythe new device of the present invention, which is a simpler, safer andlong term working device.

The stretching device may be kept in contact with the stomach wall bystomach-to-stomach sutures or staplers, in a position in which thestretching device is capable of stretching the stomach wall.Specifically, the stretching device may be invaginated by the stomachwall by means of stomach-to-stomach sutures or staplers.

The stretching device may be adapted to be placed in the stomach cavity.To this end, the stretching device may be adapted to be inserted intothe stomach cavity via a gastroscope or intraluminar instrument, and beadapted to be attached to the stomach wall by surgery. Alternatively,the stretching device may be adapted to be placed on the outside of thestomach.

In an embodiment of the invention, the stretching device comprises afirst engaging member adapted to engage a first part of the stomach walland a second engaging member adapted to engage a second part of thestomach wall close to but spaced from the first stomach part. Theoperation device is adapted to operate the first and second engagingmember to move away from each other to stretch the stomach wall portionbetween the first and second parts of the stomach such that satiety iscreated. At least one of the first and second engaging members may beadapted to at least in part be invaginated by the stomach wall bystomach-to-stomach sutures or staplers holding the engaging member inplace. In addition, at least one of the first and second engagingmembers may be adapted to be kept in place by sutures or staplersbetween the engaging member and the stomach wall. Suitably, at least oneof the first and second engaging members comprises a tissue growthpromoting structure, preferably a net like structure, adapted to be incontact with the stomach wall to secure long term attachment of thestretching device to the stomach wall.

In another embodiment of the invention, the stretching device comprisesat least one expandable body adapted to be invaginated by a portion ofthe patient's stomach wall, and the operation device comprises a fluidreservoir, which is in fluid communication with a chamber of the body.The operation device is non-invasively operable to distribute fluid fromthe fluid reservoir to the chamber of the body to expand the body suchthat the stomach wall portion is stretched, when the body isinvaginated. The fluid reservoir may be operated by manually pressingit. The operation device may comprise a reverse servo, wherein a smallvolume of fluid in the fluid reservoir is compressed with a higher forceand the chamber of the body creates a movement of a larger total volumewith less force per unit of volume. The fluid reservoir may be placedsubcutaneously or in the abdomen, and may be regulated by moving a wallof the reservoir, for example by a motor. Alternatively, a pump may beprovided for pumping fluid or air from the reservoir to the body'schamber.

The term “reversed servo means” encompasses the definition of a devicethat is controlled with a higher force and a small stroke i.e. forexample movement of a small amount of fluid with a high force controls alarger amount of fluid moving by means of very smaller force, but mayalternatively or additionally encompass the definition of a mechanismthat transfers a strong force acting on a moving element having a shortstroke into a small force acting on another moving element having a longstroke. The reversed servo means is preferably used when manual controlof the device through intact skin is possible.

In another embodiment of the invention, the device comprises a largechamber in contact with one or more smaller chambers. The chambers areadapted to communicate with fluid or air being distributed between thechambers. A reversed servo for distributing fluid between the chambersmay be provided, wherein a small volume of fluid in the large chamber iscompressed with a higher force and the smaller chamber creates amovement of a larger total volume with less force per unit of volume.The large chamber may be adapted to be invaginated in the patient'sfundus stomach wall to also treat reflux disease by restricting movementof the cardiac notch towards the diaphragm muscle of the patient,whereas the small chambers function as stretching devices to treatobesity. The large chamber may distribute fluid or air to the smallchambers to cause them to expand and stretch the stomach fundus wall.

In another embodiment of the invention, the stretching device comprisesa mechanical stretching device, wherein a motor for mechanicallyregulating the stretching device may be provided. The mechanicallyregulated stretching device may be adapted to engage a first part of thestomach wall and a second part of the stomach, wherein the mechanicallyregulated stretching device comprises a joint mechanism adapted to bemoved by the operation device. Alternatively, the stretching device maycomprise a first engaging member adapted to engage a first part of thestomach wall and a second engaging member adapted to engage a secondpart of the stomach wall close to but spaced from the first stomachpart, wherein the mechanical stretching device regulates the distancebetween the first and second parts of the stomach wall.

As an alternative, the hydraulic means described above may be used forregulating such a mechanical stretching device by the hydraulicdistribution of fluid or air.

The stretching device may be non-invasively adjustable postoperatively.

The operation device for operating the stretching device may in itssimplest form comprise a subcutaneous switch adapted to benon-invasively operated by manually pressing the switch for theoperation of the stretching device.

At least two operable stretching devices adapted to stretch at least twodifferent portions of the stomach wall may be provided, wherein thedevice is adapted to be postoperatively and non-invasively regulated.Specifically, the device may be regulated from time to time such that ata first time one of the stretching devices stretches one of the portionsof the stomach wall and at a second time the other of the stretchingdevices stretches the other portion of the stomach wall.

In another embodiment of the invention, the stretching device comprisesa body adapted to fill out a volume defined by wall portions of thestomach. The body suitably has rounded contours without too sharp edgesthat would be damaging to the patient's stomach wall. Where the body isto be invaginated it may have varying circumference to better be kept inplace invaginated by stomach wall portions of the patient. The body maybe shaped like an egg or like a kidney.

Generally, any kind of mechanical construction may be used. Anymechanical construction driven mechanically or hydraulically or anypneumatic construction may be used. Any motor or any pump or movingmaterial changing form when powered may be used to achieve the simplegoal of stretching a part of the stomach wall by moving at least twopart s of the stomach wall away from each other.

Any kind of hydraulic operation may be used. It will be appreciated thatinstead of hydraulic operation, pneumatic operation can be used, whereinair instead of hydraulic fluid is moved between a reservoir and achamber formed by the stretching device. Preferably the reservoir has alocking position to keep it in the desired position if it is handled bythe patient. To compress the reservoir it preferably stays compressedand releases after pressing again.

Any kind of hydraulic solution may be used for the stretching device.The hydraulic solution may be driven by both mechanically and poweredwith any motor or pump as well as manual.

Of course just expanding an invaginated part of the stomach alsostretches away the stomach wall which also may be achieved bothmechanically, hydraulically, pneumatically and both being powered with amotor or pump or by manual force.

According to one embodiment, a device for treating obesity of a patientis provided, the device comprises at least one operable stretchingdevice implantable in the patient and adapted to stretch a portion ofthe patient's stomach wall. The device further comprises an implantablecontrol unit for automatically controlling the operable stretchingdevice, when the control unit and stretching device are implanted, tostretch the stomach wall portion in connection with the patient eatingsuch that satiety is created.

According to another embodiment the device further comprises at leasttwo stretching devices, a first stretching device and a secondstretching device, or three or more stretching devices. According to yetanother embodiment the device further comprises an operation device foroperating the stretching device, wherein the control unit controls theoperation device to stretch the stomach wall portion, when the controlunit and stretching device are implanted.

According to yet another embodiment the device further comprising asensing device including a sensor for sensing a physical parameter ofthe patient or a functional parameter of the stretching device, whereinthe sensing device sends information relating to the parameter to thecontrol unit, and the control unit controls the stretching device basedon the information. The device could be adapted to control thestretching device to intermittently stretch the stomach wall, when thecontrol unit and stretching device are implanted.

According to one embodiment the implantable control unit is adapted tocontrol the amount of stretching performed by the stretching device onthe stomach wall, according to one embodiment by vary over time, theamount of stretching of the stomach wall and/or to stretch the stomachduring a predetermined time period.

According to one embodiment the implantable control unit is adapted tocontrol the stretching device based on the patient's food intake, theimplantable control unit could be programmable to include any of: apredetermined time period during which the stretching device iscontrolled to stretch the stomach wall, and the magnitude of stretchingapplied on the stomach wall. The operation device could be a mechanicaloperation device, hydraulic operation device, a hydraulically operatedmechanical operation device or a mechanically operated hydraulicoperation device.

According to one embodiment the sensor of the sensing device senses thepatient's food intake directly or indirectly, and the implantablecontrol unit controls the operation device to stretch the stomach wallin response to signals from the sensor.

According to yet another embodiment the implantable control unit isadapted to control the operation device to stretch the stomach wallusing more than one stretching device. This could be done by theimplantable control unit being adapted to control the first stretchingdevice, during a first time period, to stretch a first portion of thestomach wall, and the second stretching device, during a second timeperiod, to stretch a second portion of the stomach wall different fromsaid first portion of the stomach, to allow longer relaxation of thestomach wall in between stretching periods.

According to one embodiment the sensor of the sensing device is adaptedto sense a parameter related to the patients food intake such asesophagus movement, esophagus bending, esophagus motility, esophagusstretching, esophagus pressure, food passing esophagus, food in thestomach, neural activity, vagus activity, muscle activity, hormonalactivity, stomach motility, stomach stretching, stomach pressure,stomach bending, stomach filling, and/or acidity in the stomach. Thesensing device could also be adapted to senses motility, stretching,bending, pressure, movement, a hormone, neural activity, PH-level,acidity, volume, capacitance, resistance, volt, ampere, light absorptionor visualization, ultrasound reflection or absorption, bending metal,bimetal and PH.

According to one embodiment the device further comprises an implantablereservoir, wherein the operation device is hydraulically controlled bythe reservoir. The stretching device could be adapted to be controlledfrom outside the patient's body using a patient control which accordingto one embodiment could be adapted to override the control of theimplantable control unit. The implantable control unit could be adaptedto be controlled from outside the patient's body by the patient.

According to one embodiment the device further comprises an externalcontrol unit for controlling the implantable control unit from outsidethe patient's body e.g. by means of an implantable switch operable bythe patient.

According to one embodiment the device comprises a wireless remotecontrol for controlling and/or programming the implantable control unitfrom outside the patient's body. The control unit could comprise a forcecontroller, and the mechanical operation device could be controlled bythe force controller.

According to one embodiment the implantable control unit comprises apressure controller, and the hydraulic operation device is controlled bythe pressure controller.

Stretching Device

The stretching device of the device according to any of the embodimentscould comprise a first and a second engaging part, the first part couldbe adapted to be engaged to a first area of the stomach wall, and thesecond part could be adapted to be engaged to a second area of thestomach wall. The stretching device is thereby adapted to stretch aportion of the stomach wall between the first area and the second area.The stretching device could comprise a motor, such as an implantableelectrical motor, which in turn could operate at least one joint to movethe joint to stretch the stomach wall portion.

According to another embodiment the device could comprise a chamberhaving a variable volume; the chamber could be adapted to receive afluid. The device could further comprise a reservoir adapted to hold afluid and to be in fluid connection with the chamber. The stretchingdevice could further comprise a pumping device, which could be adaptedto move the fluid from the reservoir to the chamber, and therebystretching the portion of the stomach wall. According to anotherembodiment the device further comprises a second fluid connectionadapted to enable the fluid to flow back from the chamber to thereservoir during a predetermined time period.

Hydraulic

According to one embodiment the stretching device comprises a chamberadapted to have a variable volume. The chamber could comprise at leastone moveable wall portion, which could be an elastic wall portion. Thechamber could have an essentially round shape and could be adapted toreceive a fluid.

According to another embodiment the stretching device further comprisesa reservoir adapted to hold a fluid and to be in fluid connection withthe chamber, the stretching device could further comprise a pumpingdevice, which could be adapted to move the fluid from the reservoir tothe chamber via a first fluid connection interconnecting the reservoirand chamber, thereby stretching the portion of the stomach wall. It isalso conceivable that the stretching device further comprises a secondfluid connection interconnecting the chamber and reservoir and adaptedto enable the fluid to flow back from the chamber to the reservoirduring a predetermined time period.

The reservoir according to any of the embodiment could be adapted to beplaced subcutaneously or in the abdomen and the reservoir could becontrolled by moving a wall of the reservoir which could be done using amotor adapted therefore. The chamber could also comprise an electricalmotor adapted to expand the volume of the chamber.

The device could further comprise a reverse servo, wherein a smallvolume in the reservoir is compressed with a higher force and thechamber creates a movement of a larger total area with less force perarea unit.

Sensor

The sensor implanted in the patient according to any of the embodimentscould be a functional parameter sensor sensing a functional parameter ofthe device, such as the transfer of energy for charging an internalenergy source. In other embodiments the sensor is a physical parametersensor sensing a physical parameter of the patient, such as the foodintake of the patient. The sensor according to any of the embodimentscould be at least one of body temperature sensors, pressure sensors,blood pressure sensors, blood flow sensors, heartbeat sensors, breathingsensors, electrical conductivity sensors, pH sensor, light sensitivesensors, gas detection sensors and sensors sensing mechanical strain,such as a sensor adapted to sense any of contraction and relaxation ofthe Cardia.

According to one embodiment the device further comprises a feedbackdevice for sending information from inside the patient's body to theoutside thereof to give feedback information related to the functionalparameter.

Control Unit

According to one embodiment the device is controlled by a control unitadapted to control the stretching device. The control unit could beadapted to control the stretching device, or two or more stretchingdevices, in response to signals from the sensor.

According to one embodiment the control unit controls the stretchingdevices from time to time such that one of the stretching devices at afirst time stretches a first portion of the stomach wall and another ofthe stretching devices at a second time stretches a second portion ofthe stomach wall. The control unit could be adapted to be controllablefrom outside of the patient's body, e.g. through a wireless remotecontrol, which in turn could comprises at least one external signaltransmitter, which could be adapted to transmit a wireless controlsignal comprising a frequency, amplitude, or phase modulated signal or acombination thereof. According to one embodiment the at least onetransmitter is adapted to transmit a wireless control signal comprisinga analogue or a digital signal, or a combination of an analogue anddigital control signal, or a wireless control signal comprising anelectric or magnetic field, or a combined electric and magnetic field.

The control unit according to any of the embodiments could be adapted tobe implanted subcutaneously in the human patient, and could be adaptedto control a hydraulic system.

The device could further comprise a transferring member for powering thecontrol unit, the transferring member could comprise a fluidtransferring member and/or an electrical lead.

According to another embodiment the device further comprises an externaldata communicator and an implantable internal data communicatorcommunicating with the external data communicator. The internalcommunicator could be adapted to feed data related to the device fortreating obesity or the patient back to the external data communicatoror the external data communicator feeds data to the internal datacommunicator.

Energizing

For energizing the device the device could further comprise a wirelessenergy transmitter transmitting energy by at least one wireless energysignal, such as a wave signal, e.g. a sound wave signals, ultrasoundwave signals, electromagnetic wave signals, infrared light signals,visible light signals, ultra violet light signals, laser light signals,micro wave signals, radio wave signals, x-ray radiation signals and agamma radiation signals. The wireless energy signal could furthercomprise an electric or magnetic field, or a combined electric andmagnetic field.

According to yet another embodiment the device comprises an energysource adapted to power the device, which could comprise an internalenergy source which in turn could be adapted to receive energy from anexternal energy source transmitting energy in a wireless mode. Theinternal energy source could further comprise an accumulator, at leastone voltage level guard and/or at least one constant current guard.

The device could further comprise an energy-transforming device adaptedto transform energy from a first form into a second form.

Fixation

The device according to any of the embodiments could comprise a fixatingmember, which could be adapted to fixate the stretching device to thestomach wall of the patient. The fixating member could be adapted to bein contact with sutures or staplers for fixating the stretching deviceto the stomach wall of the patient. The fixating member could comprise anet like structure, which could be adapted to promote growth in of humantissue for long term fixation to the stomach wall.

System

The present invention also provides an obesity treatment systemcomprising a device for treating obesity as described above. The systemmay comprise a subcutaneous electric switch adapted to manually andnon-invasively control a function of the device for treating obesity.

The system may comprise a hydraulic device having a hydraulic reservoir,wherein the device for treating obesity is adapted to non-invasively beregulated by manually pressing the hydraulic reservoir.

The system may comprise a wireless remote control for controlling afunction of the device. The wireless remote control comprises at leastone external signal transmitter and an internal signal receiver may beprovided to be implanted in the patient. The wireless remote control isadapted to transmit at least one wireless control signal for controllingthe device. The wireless control signal may comprise a frequency,amplitude, or phase modulated signal or a combination thereof, and ananalogue or a digital signal, or a combination of an analogue anddigital signal. Alternatively, the wireless control signal comprises anelectric or magnetic field, or a combined electric and magnetic field.The remote control may transmit a carrier signal for carrying thewireless control signal. The carrier signal may comprise digital,analogue or a combination of digital and analog signals. The remotecontrol may transmit an electromagnetic carrier wave signal for carryingthe digital or analog control signal.

The system may comprise a wireless energy transmitter for non-invasivelyenergizing the device with wireless energy. The energy transmittertransmits energy by at least one wireless energy signal. The wirelessenergy signal may comprise a wave signal selected from the following: asound wave signal, an ultrasound wave signal, an electromagnetic wavesignal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a micro wave signal, a radiowave signal, an x-ray radiation signal and a gamma radiation signal.Alternatively, the wireless energy signal comprises an electric ormagnetic field, or a combined electric and magnetic field. The wirelessenergy transmitter may transmit a carrier signal for carrying thewireless energy signal. The carrier signal may comprise digital,analogue or a combination of digital and analog signals.

The system may comprise an energy-transforming device for transformingthe wireless energy from a first form into a second form energy. Theenergy-transforming device may directly during energy transfer operatethe device with the second form energy. The second form energy maycomprise a direct current or pulsating direct current, or a combinationof a direct current and pulsating direct current. The second form energymay comprise an alternating current or a combination of a direct andalternating current. An accumulator may be provided, wherein the secondform energy is used at least partly to charge the accumulator. Theenergy of the first or second form may comprise magnetic energy, kineticenergy, sound energy, chemical energy, radiant energy, electromagneticenergy, photo energy, nuclear energy or thermal energy. One of theenergy of the first form and the energy of the second form may benon-magnetic, non-kinetic, non-chemical, non-sonic, non-nuclear ornon-thermal.

The system may comprise an energy source adapted to power the device.The energy source may comprise an internal energy source adapted toreceive energy from an external energy source transmitting energy in awireless mode. The internal energy source is charged by the energy inthe wireless mode.

The system may comprise a feedback device for sending information frominside the patient's body to the outside thereof to give feedbackinformation related to a functional parameter.

The system may comprise a sensor sensing a parameter, such as afunctional parameter of the system, which is correlated to the transferof energy for charging an internal energy source. An internal controlunit may be provided for controlling the operation device of the devicein response to the sensor sensing a functional parameter. Alternatively,sensor senses a physical parameter of the patient. The physicalparameter may be one of body temperature, blood pressure, blood flow,heartbeats and breathing. The physical parameter sensor may be apressure or motility sensor, or a sensor sensing measure, bending,stretching or food intake. The internal control unit may control theoperation device in response to the sensor sensing the physicalparameter. An internal control unit may be provided for receivinginformation from the sensor.

The operation device of the device may comprise a motor or a pump.Specifically, the operation device may comprise an electric motor. Theoperation device may be electrically powered, may be a hydraulicoperation device or may be a pneumatic operation device. The transmittedenergy, directly in its wireless form may affect the operation device tocreate kinetic energy to operate the stretching device of the deviceduring energy transfer.

The system may comprise a feedback device for sending information frominside the patient's body to the outside thereof to give feedbackinformation related to a functional parameter.

The system may comprise an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator, wherein the internal communicator is adapted to feed datarelated to the device for treating obesity or the patient back to theexternal data communicator or the external data communicator feeds datato the internal data communicator.

The system may comprise implantable electrical components including atleast one voltage level guard and/or at least one constant currentguard.

Methods

-   -   The present invention also provides methods as listed below:    -   a) A method for surgically treating an obese patient, the method        comprising the steps of:    -   cutting an opening in the abdominal wall of the patient,    -   dissecting an area around the stomach,    -   placing a device for treating obesity as described above,        engaging the stomach wall of the patient, and suturing the        stomach wall.    -   The method may further comprise the additional step of:        postoperatively regulating the stretching device to stretch a        part of the stomach wall to affect the appetite of the patient,        wherein the step of regulating the stretching device is        controlled from outside the patient's body.    -   The method may further comprise the additional steps of: placing        an additional device for treating obesity as described above,        engaging the stomach wall of the patient, stretching a first        part of the stomach wall by means of the device for treating        obesity, and stretching a second part of the stomach wall by        means of the additional device for treating obesity.    -   b) A method for surgically placing a device for treating obesity        in a patient via a laparoscopic abdominal approach, the method        comprising the steps of: inserting a needle or a tube like        instrument into the abdomen of the patient's body,    -   using the needle or a tube like instrument to fill the patient's        abdomen with gas thereby expanding the patient's abdominal        cavity,    -   placing at least two laparoscopic trocars in the patient's body,        inserting a camera through one of the laparoscopic trocars into        the patient's abdomen,    -   inserting at least one dissecting tool through one of the at        least two laparoscopic trocars and dissecting an intended        placement area of the patient, and    -   placing a device for treating obesity as described above,        engaging the stomach wall.    -   c) A method of using the system for treating obesity as        described above, comprising the step of regulating the        stretching device postoperatively to stretch a portion of the        stomach wall to affect the appetite of the patient, wherein the        step of regulating the stretching device is performed        non-invasively. The stretching device comprises a mechanical or        hydraulic stretching device. The hydraulic stretching device may        comprise a reservoir, for moving gel or gas or fluid to or from        the stretching device. The reservoir may be placed        subcutaneously for being reached by the patients hand for moving        fluid manually to or from the stretching device. The stretching        device may be powered by an internal energy source for        stretching or releasing the stretching device, wherein by means        of a control device controlling the power from an internal        control unit or from the outside the patient's body. A wireless        energy transmitter for wireless transfer of energy powers the        operation device to get the stretching device to directly during        energy transfer cause the stretching device to stretch the        stomach wall. A wireless energy transmitter for wireless        transfer of energy charges the internal energy source. A        reversed servo may be provided, wherein moving, in a closed        hydraulic system, a small amount of fluid, a larger movement of        fluid is achieved in a second larger closed hydraulic system,        wherein the small amount of fluid is moved with by a higher        force per area unit than the large volume. An invaginated        stretching device in the fundus stomach wall of the patient is        adapted to be adjustable, wherein the stretching device placed        invaginated in the stomach fundus wall is adapted to be adjusted        and stretching the stomach fundus wall thereby creating satiety.    -   The method may further comprise sending feedback information        from inside the body to the outside thereof to give feedback        related to the functional parameters of the device.        Alternatively, the method may further comprise sending feedback        information from inside the body to the outside thereof to give        feedback related to the physical parameters of the patient. The        functional parameter of the device may be correlated to the        transfer of energy for charging the internal energy source. The        device is programmable from outside the patient's body.    -   The method may further comprise the steps of:    -   sensing a physical parameter of the patient or a functional        parameter of the device, and    -   sending sensing information to a control unit adapted for        regulating the stretching device.    -   The method may further comprise the steps of:    -   sensing a physical parameter of the patient or a functional        parameter of the device, and    -   sending sensing information to a control unit adapted for        regulating the charging of the internal energy source.    -   The method may further comprise subcutaneously placing a        reversed servo having a small control reservoir and moving a        small volume from the control reservoir with a higher force per        area unit, creating a larger movement of the stretching device        with less force per area unit.    -   The method may further comprise performing the non-invasive        regulation by manually pressing a subcutaneous switch.    -   The method may further comprise performing the non-invasive        regulation by a wireless remote control.    -   The method may further comprise performing the non-invasive        regulation by a wireless energy transmitter.    -   The method may further comprise powering the device for treating        obesity by an internal energy source.    -   The method may further comprise powering the device for treating        obesity by an external energy source transmitting wireless        energy, wherein the energy source comprises an external energy        source transmitting wireless energy.    -   The method may further comprise transmitting wireless energy        from an external energy source to charge a rechargeable internal        energy source.    -   d) A method of using a device as described above, wherein the        stretching device comprises a main body including a large        chamber in contact with one or more smaller reservoirs/chambers        adapted to stretch the stomach wall, wherein the chambers are        adapted to communicate with fluid or air being moved between the        chambers.    -   e) A method of using a device as described above, wherein the        large chamber are adapted to, with its main volume to be the        stretching device's most important volume and wherein, the small        chambers are as the stretching devices stretching the stomach        wall to treat obesity, wherein the main chamber is communicating        with fluid or gel to the small chambers causing the stretching        effect in the stomach fundus wall thereby treating obesity.    -   f) A method of using a device as described above, comprising        treating reflux disease by invaginating the large chamber with        its main volume in the fundus stomach wall thereby restricting        movement of the stomach notch towards the diaphragm muscle of        the patient, and stretching the stomach fundus wall using the        small chambers, communicating with fluid or air from the large        chamber to the small chambers causing a stretching effect in the        stomach fundus wall thereby treating obesity.

A gastroscopic method of treating obesity of a patient using a deviceadapted to stretch a part of the stomach wall of the patient isprovided. The method comprises the steps of: inserting the device intothe stomach of the patient through the esophagus, placing the device incontact with the stomach wall, fixating the device to the stomach wallsuch that the device can stretch a part of the stomach wall.

According to one embodiment the step of fixating the device comprisesthe steps of: fixating a first portion of the device to a first part ofthe stomach wall, and fixating a second portion of the device to asecond part of the stomach wall. The step of fixating the first andsecond portion of the device could comprise the step of invaginating thefirst and second portion with stomach to stomach sutures or staples.

According to one embodiment the method comprises the additional stepsof: placing a second device adapted to stretch a portion of the stomachwall in contact with the stomach, fixating the second device to thestomach wall, stretching a first portion of the stomach wall using thefirst device, and stretching a second part of the stomach wall using thesecond device.

According to one embodiment the stretching of the second portioncomprises the step of: time delaying stretching the second part, with apredetermined time delay.

The method according to any of the embodiment could further comprise thesteps of: inserting a gastroscope into the stomach of the patient,pushing a portion of the stomach wall to prepare a pouch on the outsideof the stomach, inserting the device into the pouch, placed on theinside of the stomach wall, suturing or stapling to enclose the devicein the pouch before or after the insertion of the device into the pouch.

According to one embodiment the method further comprises the steps of:inserting a gastroscope into the stomach of the patient, pulling aportion of the stomach wall to prepare a pouch on the inside of thestomach, creating a hole in the stomach wall into the pouch, insertingthe device into the pouch, through the hole in the stomach wall,suturing or stapling the pouch, before or after the insertion of thedevice through the hole.

The method could further comprise the step of placing a transferringmember from the device to a control unit, which could be a fluidtransferring member and/or a member adapted to transfer electricalpower.

The method could further comprise the step of placing a control unit,which can be placed subcutaneously in the patient.

According to one embodiment the step of placing a transferring memberfrom the device to a control unit comprises the steps of: cutting anopening in the abdomen of the patient, connecting the transferringmember to the control unit, inserting the control unit into the openingin the skin of the patient, and fixating the control unitsubcutaneously.

According to one embodiment the method further comprises the step ofplacing a transferring member from the device to a control unitcomprises the steps of: cutting an opening in the abdomen of thepatient, connecting the transferring member to the control unit,inserting the control unit into the opening in the skin of the patient,to be placed in the abdominal cavity. The step of placing the controlunit could comprise the steps of: fixating the control unit to theabdominal wall.

Stretching

According to one embodiment of the method according to any of theembodiments the method comprises the additional step of postoperativelyand non-invasively regulating the device to stretch a portion of thestomach wall to affect the appetite of the patient.

The step of postoperatively and non-invasively regulating the device tostretch a part of the stomach wall comprises the step of increasing thedistance between the first part of the stomach wall and the second partof the stomach wall.

According to one embodiment the step of regulating the device isperformed from outside the patient's body, whereas according to otherembodiments the method step of regulating the device comprisesregulating the device by the implantable control unit from inside thebody.

According to one embodiment the step of regulating the device comprisesfrom time to time regulate different devices to at a first time stretcha first portion of the stomach wall and at a second time stretch asecond portion of the stomach wall.

According to one embodiment the method comprises placing two or moredevices in contact with the stomach and from time to time regulatedifferent device to stretch a part of the stomach wall.

Manual

The step of placing a device in contact with the stomach could compriseplacing a device adapted to have a variable volume in contact with thestomach, the volume could be variable through at least one moveable wallportion, which in turn could be at least one elastic wall portion.

The device according to any of the embodiments could have an essentiallyround shape, or an egg shape.

The device could further comprise a subcutaneous switch, and the methodcould further comprise pressing the switch for manually andnon-invasively regulating the device.

According to one embodiment the step of regulating the device comprisesthe step of moving a fluid from a reservoir to the device.

According to one embodiment the device could comprise a pump, and themethod could comprise the step of; pumping a fluid from the reservoir tothe device to stretch the stomach wall.

The step of moving a fluid from a reservoir to the device could comprisethe step of moving a wall portion of the reservoir.

The step of regulating the device could comprise the step of manuallypressing the reservoir, which could be placed subcutaneously or in theabdomen.

Mechanical

According to one embodiment the step of increasing the distance betweenthe first part of the stomach wall and the second part of the stomachwall comprises the step of moving fluid into a chamber having a variablevolume.

Automatic

According to one embodiment the step of placing a device in contact withthe stomach comprises placing a device adapted to have a variable volumein contact with the stomach.

The device could be adapted to have a variable volume comprising atleast one moveable wall portion, which could comprise at least oneelastic wall portion.

The device could have an essentially round shape, or an essentiallyegg-like shape.

The device could further comprise a subcutaneous switch, and the methodcould further comprise pressing the switch for non-invasively regulatingthe device.

The step of regulating the device could comprise the step of moving afluid from a reservoir to the device, which in turn could comprise thesteps of: operating a pumping device, the pumping device moving thefluid from the reservoir to the device, and the device expanding involume and thereby stretching the portion of the stomach wall.

The method could further comprise the step of the fluid flowing backfrom the device to the reservoir, thereby releasing the stretching ofthe stomach wall.

According to one embodiment the method could comprise the step of:sensing a variable using an implantable sensor, interpreting the sensedvariable and using the interpreted variable to control the device.

According to another embodiment the step of controlling the devicecomprises the steps of: operating a pumping device, for moving the fluidfrom a reservoir to the device, and the device expanding in volume andthereby stretching the portion of the stomach wall.

According to one embodiment the method comprises the step of the fluidflowing back from the device to the reservoir thereby releasing thestretching of the stomach wall.

The step of sensing a variable could comprise the step of sensing avariable connected to the food intake of the patient, which step couldcomprise the step of sensing a variable connected to the food intake ofthe patient is resulting in a increased stretching of the stomachportion, and thereby feeling of satiety by the patient.

Mechanical

According to one embodiment the step of increasing the distance betweenthe first part of the stomach wall and the second part of the stomachwall comprises the step of moving fluid into a chamber having a variablevolume.

The method could further comprise the step of moving fluid from areservoir to the chamber having a variable volume. The step of moving afluid from a reservoir to the device could comprise the steps of:operating a pumping device, the pumping device moving the fluid from thereservoir to the device, and the device expanding in volume and therebystretching the portion of the stomach wall.

According to one embodiment the step of operating the pumping devicecomprises the step of operating the pumping device using a wirelessremote control.

According to one embodiment the method further comprises the step of thefluid flowing back from the device to the reservoir thereby releasingthe stretching of the stomach wall.

According to one embodiment the step of increasing the distance betweenthe first part of the stomach wall and the second part of the stomachwall comprises the step of operating a motor adapted increase thedistance between the first part of the stomach wall and the second partof the stomach wall, thereby stretching a portion of the stomach wall.Operating the motor could comprise the step of operating the motor usinga wireless remote control.

According to one embodiment the method further comprises the step of:sensing a variable using an implantable sensor, interpreting the sensedvariable, using the interpreted variable to control the device.

According to one embodiment the method comprises the steps of: operatinga pumping device, the pumping device moving the fluid from a reservoirto the chamber, and the chamber being filled with the fluid increasingthe distance between the first part of the stomach wall and the secondpart of the stomach wall and thereby stretching the portion of thestomach wall.

According to one embodiment the method further comprises the step of thefluid flowing back from the device to the reservoir thereby releasingthe stretching of the stomach wall.

According to one embodiment the step of sensing a variable comprises thestep of sensing a variable connected to the food intake of the patient.

According to one embodiment the method further comprises the step of:sensing a variable using an implantable sensor, interpreting the sensedvariable, using the interpreted variable to control the device. The stepof sensing a variable could comprise the step of sensing a variableconnected to the food intake of the patient.

The step of increasing the distance between the first part of thestomach wall and the second part of the stomach wall could comprise thestep of operating a mechanical device adapted increase the distancebetween the first part of the stomach wall and the second part of thestomach wall, thereby stretching a portion of the stomach wall.

According to one embodiment the device comprises mechanical membersadapted to move for stretching a portion of the stomach wall between thefirst and second part of the stomach wall. The mechanical members couldbe moving for stretching a portion of the stomach wall using the motor.

According to one embodiment the step of stretching a portion of thestomach wall comprises the step of operating at least one mechanicaldevice for stretching a portion of the stomach wall.

According to one embodiment the method comprises the step ofinvaginating the mechanical device in the stomach wall with stomach tostomach sutures.

According to one embodiment the method comprises the step of expandingthe mechanical device in the invaginated stomach wall to stretch thestomach wall.

According to one embodiment the method comprises a motor, expanding thestomach wall, according to another embodiment the method comprise amemory metal, expanding the stomach wall.

According to another embodiment the method comprises a hydraulicallycontrolled mechanical device, expanding the stomach wall.

Placing

According to one embodiment the step of placing a device comprisesplacing the device in connection with the stomach wall, on the outsidethereof, which could comprise the step of placing the device in thestomach fundus wall of the patient.

The step of placing a device could comprise the step of placing thedevice in connection with the stomach wall, on the inside thereof, whichcould comprise the step of

placing the device in the stomach fundus wall of the patient.

Fixation

The step of fixating the at least one device comprises suturing orstapling the at least one device to the stomach wall.

The step of fixating the at least one device could comprisein-vaginating in the stomach wall with stomach-to-stomach sutures orstaples, in other embodiments the step of fixating the at least onedevice could comprise placing a mesh adapted to be fixated to thestomach wall by means of fibrotic tissue.

The mesh could be additionally supported by sutures or staples and couldcomprise a structure adapted to promote the growth in of human tissue,such as a net like structure.

-   -   An additional method is provided, the method comprising the        steps of: creating a hole in the stomach wall; introducing the        stretching device into the stomach by means of a instrument;        moving the device through the hole and placing it on the outside        of the stomach wall; creating a pouch of a portion of the        stomach wall inside the stomach cavity, with the device placed        against the outside of the stomach wall; invaginating the device        in the pouch to the stomach wall; and sealing the hole,        preferably with sutures or staples.    -   An additional method is provided, the method comprising the        steps of: creating a hole in the stomach wall; creating, by        means of the instrument, a pouch of a portion of the stomach        wall on the inside of the stomach cavity; introducing the device        into the stomach by means of the instrument; moving the device        through the hole and placing it on the outside of the stomach        wall; introducing the device by means of the instrument into the        pouch; invaginating the device to the stomach wall; and sealing        the hole, preferably with sutures or staples.    -   According to one embodiment the method, further comprises        providing a device for regulating the stretching device from the        outside of the patient's body; and operating the device to        regulate the device.    -   According to another embodiment the method further comprises the        steps of: cutting the skin of the patient, inserting a tube into        the abdominal cavity of the patient, connecting the tube to the        volume filling device, filling the device with fluid injected        through the tube.    -   According to another embodiment the method further comprises the        steps of: subcutaneously placing an injection port and        connecting the tube to the injection port.    -   According to another embodiment the method further comprises the        step of providing a tube connected to the stretching device        through the hole and further up to the abdominal wall or passing        through the abdominal wall.    -   According to another embodiment the method further comprises the        steps of: cutting the skin of the patient, receiving the tube        from the abdominal cavity of the patient, connected to the        stretching device, and filling the device with fluid injected        through the tube.    -   According to another embodiment the method the method further        comprises the steps of: subcutaneously placing an injection        port, and connecting the tube to the injection port.

Instrument

An instrument for placing a device adapted to stretch a part of thestomach wall of a patient in connection with the stomach wall is furtherprovided. The instrument comprises: a holding member adapted toreleaseably hold the device, an insertion member adapted to insert thedevice through the stomach wall, and a fixating member, adapted toassist in the fixation of the device to the stomach wall, on the outsidethereof.

The instrument could further comprise a cutting member for cutting ahole in the stomach wall, an optical member for viewing in the area ofthe stomach. The fixation member could be adapted for suturing thedevice to the stomach wall, on the inside thereof, or for stapling thedevice to the stomach wall, on the inside thereof, or for invaginatingat least a part of the device in the stomach wall withstomach-to-stomach sutures, on the inside thereof, or for invaginatingat least a part of the device in the stomach wall withstomach-to-stomach staplers, on the inside thereof, however theinstrument could be adapted to perform the method from the outsidethereof.

The instrument could further comprise a special holding device, whichcould comprise a special holding device adapted to hold the stomachusing vacuum or using mechanical holding members.

A surgical or laparoscopic method of treating obesity of a patient usinga device adapted to stretch a portion of the stomach wall of the patientis provided. The method comprises the steps of: cutting a hole in theabdominal wall of the patient, dissecting an area around the stomach,placing the device in contact with the stomach, and fixating, direct orindirect, through invagination of the stomach wall the, device to thestomach wall such that the device can stretch a portion of the stomachwall.

According to one embodiment the method the step of fixating the devicecomprises the steps of: fixating a first portion of the device to afirst part of the stomach wall, and fixating a second portion of thedevice to a second part of the stomach wall, wherein the first andsecond portion of the device is fixated, such that the device is adaptedto stretch a portion of the stomach wall between the first and secondpart of the stomach wall.

According to another embodiment, the device is a first device, and themethod comprises the additional steps of: fixating direct or indirectthrough invagination of the stomach wall a second device adapted tostretch a part of the stomach wall in contact with the stomach, fixatingthe second device to the stomach wall, stretching a first portion of thestomach wall using the first device, and stretching a second portion ofthe stomach wall using the second device.

According to another embodiment the method comprises the additional stepof postoperatively and non-invasively regulating the device to stretch aportion of the stomach wall to affect the appetite of the patient.

A surgical or laparoscopic method of treating obesity of a patient usinga device adapted to stretch a portion of the stomach wall of the patientis further provided.

The method comprises the steps of: inserting a needle or tube likeinstrument into the abdomen of the patients body, using the needle ortube like instrument to fill the patient's body with gas, placing atleast two laparoscopic trocars in the patient's body, inserting a camerathrough one of the laparoscopic trocars in the patient's body, insertingat least one dissecting tool through one of the at least twolaparoscopic trocars, dissecting an area of the stomach, introducing adevice into the abdominal cavity, placing the device on the outside ofthe stomach wall, engaging the stomach wall.

According to another embodiment the method comprises the step ofpostoperatively and noninvasively regulating the device to stretch apart of the stomach wall comprises the step of increasing the distancebetween the first part of the stomach wall and the second part of thestomach wall.

According to another embodiment the step of regulating the device isperformed from outside the patient's body.

According to another embodiment the step of regulating the devicecomprises from time to time regulate different device to at a first timestretch a first portion of the stomach wall and at a second time stretcha second portion of the stomach wall.

According to another embodiment the method comprises placing two or moredevice in contact with the stomach and from time to time regulatedifferent device to stretch a portion of the stomach wall. The step offixating the first and second portion of the device could furthercomprise the step of invaginating the first and second portion withstomach to stomach sutures or staplers.

According to another embodiment, the device further comprises animplantable control unit, wherein the method step of regulating thedevice comprises regulating the device by the implantable control unitfrom inside the body.

According to another embodiment the stretching of the second portioncomprises the step of:

time delaying stretching the second part, with a predetermined timedelay.

Manual

According to another embodiment the step of placing a device in contactwith the stomach comprises placing a device adapted to have a variablevolume in contact with the stomach, which could be regulated by means ofat least one moveable wall portion, which in turn could be an elasticwall portion. The device could have an essentially round shape, or eggshape.

According to another embodiment the device comprises a subcutaneousswitch, and the method further comprises pressing the switch formanually and non-invasively regulating the device. Regulating the devicecould comprise the step of moving a fluid from a reservoir to thedevice.

According to another embodiment the device further comprises a pump, andthe method further comprises the step of; pumping a fluid from thereservoir to the device to stretch the stomach wall.

According to another embodiment the step of moving a fluid from areservoir to the device comprises the step of moving a wall portion ofthe reservoir, which could be done through the step of manually pressingthe reservoir.

The reservoir, according to any of the embodiments could be placedsubcutaneously or in the abdomen.

Mechanical

According to another embodiment the step of increasing the distancebetween the first part of the stomach wall and the second part of thestomach wall comprises the step of moving fluid into a chamber having avariable volume.

Automatic

According to another embodiment the step of placing a device in contactwith the stomach comprises placing a device adapted to have a variablevolume in contact with the stomach.

The device adapted to have a variable volume could comprise at least onemoveable wall portion, which in turn could be an elastic wall portion.

The device according to any of the embodiments could comprise asubcutaneous switch, and the method could further comprise pressing theswitch for noninvasively regulating the device.

According to another embodiment the step of regulating the devicecomprises the step of moving a fluid from a reservoir to the device. Thestep of moving a fluid from a reservoir to the device could comprise thesteps of: operating a pumping device, for moving the fluid from thereservoir to the device, and the device expanding in volume and therebystretching the portion of the stomach wall.

According to another embodiment the method further comprises the step ofthe fluid flowing back from the device to the reservoir, therebyreleasing the stretching of the stomach wall.

According to another embodiment the method further comprises the stepof: sensing a variable using an implantable sensor, interpreting thesensed variable, using the interpreted variable to control the device.

According to another embodiment the step of controlling the devicecomprises the steps of: operating a pumping device, for moving the fluidfrom a reservoir to the device, and the device expanding in volume andthereby stretching the portion of the stomach wall.

According to another embodiment the method further comprises the step ofthe fluid flowing back from the device to the reservoir therebyreleasing the stretching of the stomach wall.

The step of sensing a variable could comprise the step of sensing avariable connected to the food intake of the patient, which could resultin an increased stretching of the stomach portion, and thereby thefeeling of satiety by the patient.

Mechanical

According to another embodiment the step of increasing the distancebetween the first part of the stomach wall and the second part of thestomach wall could comprise the step of moving fluid into a chamberhaving a variable volume.

According to another embodiment the step moving fluid into a chambercomprises the step of moving fluid from a reservoir to the chamberhaving a variable volume.

According to another embodiment the step of moving a fluid from areservoir to the device comprises the steps of: operating a pumpingdevice, the pumping device moving the fluid from the reservoir to thedevice, and the device expanding in volume and thereby stretching theportion of the stomach wall.

According to another embodiment the step of operating the pumping devicecomprises the step of operating the pumping device using a wirelessremote control.

According to another embodiment the method further comprises the step ofthe fluid flowing back from the device to the reservoir therebyreleasing the stretching of the stomach wall.

According to another embodiment the step of increasing the distancebetween the first part of the stomach wall and the second part of thestomach wall comprises the step of operating a motor adapted increasethe distance between the first part of the stomach wall and the secondpart of the stomach wall, thereby stretching a portion of the stomachwall.

The step of operating the motor could comprise the step of operating themotor using a wireless remote control.

According to another embodiment the method could further comprises thestep of: sensing a variable using an implantable sensor, interpretingthe sensed variable, using the interpreted variable to control thedevice.

According to another embodiment the step of controlling the device couldcomprise the steps of: operating a pumping device, for moving the fluidfrom a reservoir to the chamber, and the chamber being filled with thefluid increasing the distance between the first part of the stomach walland the second part of the stomach wall and thereby stretching theportion of the stomach wall.

According to another embodiment the method further comprise the step ofthe fluid flowing back from the device to the reservoir therebyreleasing the stretching of the stomach wall.

According to another embodiment the step of sensing a variable comprisesthe step of sensing a variable connected to the food intake of thepatient.

According to another embodiment the method further comprises the stepof: sensing a variable using an implantable sensor, interpreting thesensed variable, using the interpreted variable to control the device.The step of sensing a variable could comprise the step of sensing avariable connected to the food intake of the patient. The step ofincreasing the distance between the first part of the stomach wall andthe second part of the stomach wall could comprise the step of operatinga mechanical device adapted increase the distance between the first partof the stomach wall and the second part of the stomach wall, therebystretching a portion of the stomach wall. The first and second portionsof the device could comprise mechanical members adapted to move forstretching a portion of the stomach wall between the first and secondpart of the stomach wall.

According to another embodiment the method comprises a motor, whereinthe mechanical members is moving for stretching a portion of the stomachwall using the motor.

According to another embodiment the step of stretching a portion of thestomach wall comprises the step of operating at least one mechanicaldevice for stretching a portion of the stomach wall.

According to another embodiment the step of invaginating the mechanicaldevice in the stomach wall comprises invaginating with stomach tostomach sutures.

According to another embodiment the method further comprises the step ofexpanding the mechanical device in the invaginated stomach wall tostretch the stomach wall.

According to another embodiment the invaginated mechanical devicecomprises a motor, expanding the invaginated mechanical device.

The device could further comprise a memory metal or a hydraulicallycontrolled mechanical device, expanding the stomach wall.

Placing

According to another embodiment the step of placing a device comprisesplacing the device in connection with the stomach wall, on the outsidethereof, or in the stomach fundus wall, or in connection with thestomach wall, on the inside thereof.

According to another embodiment the step of placing a device inconnection with the stomach wall, on the inside thereof could comprisethe steps of: cutting a hole in the stomach wall, and inserting thedevice through the hole in the stomach wall.

According to another embodiment the step of placing a device comprisesplacing the device in the stomach fundus wall of the patient.

Fixation

According to another embodiment the step of fixating the at least onedevice comprises suturing or stapling the at least one device to thestomach wall, e.g. by means of stomach-to-stomach sutures or staplers.

The step of fixating the at least one device could comprise placing amesh adapted to be fixated to the stomach wall by means of fibrotictissue. The mesh could be additionally supported by sutures or staplersand adapted to promote the growth in of human tissue, such as a net likestructure.

Control Unit

According to another embodiment the method could comprise the step ofplacing a transferring member from the device to a control unit. Thetransferring member could comprise a fluid transferring member, or atransferring member adapted to transfer electrical power.

According to another embodiment the method further comprises the step ofplacing the control unit, which could be placed subcutaneously in thepatient.

According to another embodiment the step of placing the control unitsubcutaneously further comprises the steps of: inserting the controlunit into the hole in the abdomen of the patient, and fixating thecontrol unit.

An additional method is also provided, the method comprising the stepsof: creating a hole in the stomach wall; introducing the stretchingdevice into the abdomen; moving the device through the hole and placingit on the inside of the stomach wall; creating a pouch of a portion ofthe stomach wall outside the stomach cavity, with the device placedagainst the inside of the stomach wall; invaginating the device in thepouch to the stomach wall; and sealing the hole, preferably with suturesor staples.

According to another embodiment the method according to any of theembodiments could comprise the steps of: creating a hole in the stomachwall; moving the device through the hole and placing it on the inside ofthe stomach wall; introducing the device by means of the instrument intothe pouch; and sealing the hole, preferably with sutures or staplers.

According to another embodiment the method further comprises providing adevice for regulating the stretching device from the outside of thepatient's body; and operating the device to regulate the device.

According to another embodiment the device comprises an implantablecontrol unit and the method further comprises the steps of; providing animplanted control unit for regulating the stretching device from theinside of the patient's body; and operating the device to regulate thedevice.

The method could further comprise the steps of subcutaneously placing aninjection port and connecting a tube connected to the device to theinjection port.

According to another embodiment the method further comprises the step ofproviding a tube connected to the stretching device through the hole andfurther up to the abdominal wall or passing through the abdominal wall.

According to another embodiment the method further comprises the stepsof:

receiving a tube from the abdominal cavity of the patient, connected tothe stretching device, and filling the device with fluid injectedthrough the tube.

According to another embodiment the method could further comprise thesteps of: subcutaneously placing an injection port, and connecting thetube to the injection port.

The method could further comprise the additional step of postoperativelyand non-invasively regulating the device to stretch a part of thestomach wall to affect the appetite of the patient.

According to another embodiment the method comprises the additional stepof filling the device with a fluid.

According to another embodiment the method could comprise the additionalstep of placing an internal control unit within the patient's body.

According to one embodiment the method further comprises the additionalstep of connecting the internal control unit to the device, which couldbe done hydraulically or using electrical wires.

An additional surgical or laparoscopic method of treating obesity of apatient using a device adapted to stretch a portion of the stomach wallof the patient is provided. The method comprising the steps of:inserting a needle or tube like instrument into the abdomen of thepatients body, using the needle or tube like instrument to fill thepatient's body with gas, placing at least two laparoscopic trocars inthe patient's body, inserting a camera through one of the laparoscopictrocars in the patient's body, inserting at least one dissecting toolthrough one of the at least two laparoscopic trocars, dissecting an areaof the stomach, introducing a device into the abdominal cavity,invaginating the device on the outside of the stomach wall with stomachto stomach sutures or staplers and postoperatively stretching theinvaginated stomach wall portion by operating the device.

According to another embodiment the method comprises the additional stepof; introducing a second or more device into the abdominal cavity,invaginating the second or more device on the outside of the stomachwall with stomach to stomach sutures or staplers and postoperativelystretching the invaginated stomach wall portion by operating the secondor more device.

According to another embodiment the method comprises the additional stepof; postoperatively stretching the invaginated stomach wall portion atthe first or second or more parts of the device independent from eachother.

An additional surgical or laparoscopic method of treating obesity of apatient using a device adapted to stretch a portion of the stomach wallof the patient is provided. The method comprises the steps of: insertinga needle or tube like instrument into the abdomen of the patients body,using the needle or tube like instrument to fill the patient's body withgas, placing at least two laparoscopic trocars in the patient's body,inserting a camera through one of the laparoscopic trocars in thepatient's body, inserting at least one dissecting tool through one ofthe at least two laparoscopic trocars, dissecting an area of thestomach, introducing a device into the abdominal cavity, invaginating afirst part of the stretching device placed on the outside of the stomachwall with stomach to stomach sutures or staplers and invaginating asecond part of the stretching device, separate from the first part,placed on the outside of the stomach wall with stomach to stomachsutures or staplers and postoperatively stretching the stomach wallportion between the first and second part by operating the device.

According to another embodiment the method comprises the additional stepof; introducing a second or more device into the abdominal cavity,invaginating a first part of the stretching second or more device placedon the outside of the stomach wall with stomach to stomach sutures orstaplers, invaginating a second part of the second or more stretchingdevice, separate from the first part, placed on the outside of thestomach wall with stomach to stomach sutures or staplers, andpostoperatively stretching the stomach wall portion between the firstand second part by operating the second or more device.

According to another embodiment the method comprises the additionalsteps of; invaginating a third or more part of the stretching deviceplaced on the outside of the stomach wall, separate from the first orsecond part, with stomach to stomach sutures or staplers andpostoperatively stretching the stomach wall portion between anycombination of the first and second part and third or more parts, byoperating the device.

A surgical method of treating obesity of a patient using a deviceadapted to stretch a portion of the stomach wall of the patient, themethod comprising the steps of: cutting the skin of a human patient,dissecting an area of the stomach, introducing a device into theabdominal cavity, invaginating the device on the outside of the stomachwall with stomach to stomach sutures or staplers, and postoperativelystretching the invaginated stomach wall portion by operating the device.

The method could further comprise the additional step of; introducing asecond or more device into the abdominal cavity, invaginating the secondor more device on the outside of the stomach wall with stomach tostomach sutures or staplers, and postoperatively stretching theinvaginated stomach wall portion by operating the second or more device.

According to another embodiment the method comprises the additionalsteps of; postoperatively stretching the invaginated stomach wallportion at the first or second or more parts of the device independentfrom each other.

An additional surgical method of treating obesity of a patient using adevice adapted to stretch a portion of the stomach wall of the patientis provided. The method comprising the steps of: cutting the skin of ahuman patient, dissecting an area of the stomach, introducing a deviceinto the abdominal cavity, invaginating a first part of the stretchingdevice placed on the outside of the stomach wall with stomach to stomachsutures or staplers, invaginating a second part of the stretchingdevice, separate from the first part, placed on the outside of thestomach wall with stomach to stomach sutures or staplers, andpostoperatively stretching the stomach wall portion between the firstand second part by operating the device.

According to another embodiment the method comprises the additional stepof; introducing a second or more device into the abdominal cavity,invaginating a first part of the stretching second or more device placedon the outside of the stomach wall with stomach to stomach sutures orstaplers, invaginating a second part of the second or more stretchingdevice, separate from the first part, placed on the outside of thestomach wall with stomach to stomach sutures or staplers, andpostoperatively stretching the stomach wall portion between the firstand second part by operating the second or more device.

According to another embodiment the method further comprises the stepsof invaginating a third or more part of the stretching device placed onthe outside of the stomach wall, separate from the first or second part,with stomach to stomach sutures or staplers, and postoperativelystretching the stomach wall portion between any combination of the firstand second part and third or more parts, by operating the device.

According to another embodiment the method comprises the additionalsteps of postoperatively and noninvasively regulating the device tostretch a part of the stomach wall to affect the appetite of thepatient.

The method according to any embodiment could further comprise the stepof filling the device with a fluid.

According to another embodiment the method comprises the additional stepof placing an internal control unit within the patient's body, andconnecting the internal control unit to the device, which could be donehydraulically or using electrical wires.

Instrument

An instrument for placing a device adapted to stretch a part of thestomach wall of a patient in connection with the stomach wall is furtherprovided. The instrument comprises: a holding member adapted toreleaseably hold the device, and a fixating member, adapted to assist inthe fixation of the device to the stomach wall, on the outside thereof.

The instrument could further comprise an optical member for viewing inthe area of the stomach.

The instrument could comprise a fixation member adapted to suturing thedevice to the stomach wall, on the outside thereof.

According to another embodiment the fixation member is adapted forstapling the device to the stomach wall, on the outside thereof, and inother embodiments the fixation member is adapted for invaginating atleast a part of the device in the stomach wall with stomach-to-stomachsutures, on the outside thereof.

According to another embodiment the fixation member could be adapted forinvaginating at least a part of the device in the stomach wall withstomach-to-stomach staplers, on the outside thereof.

An instrument for placing a device adapted to stretch a part of thestomach wall of a patient in connection with the stomach wall is furtherprovided. The instrument comprises: a holding member adapted toreleaseably hold the device, an insertion member adapted to insert thedevice through the stomach wall, and a fixating member, adapted toassist in the fixation of the device to the stomach wall, on the insidethereof.

The instrument could further comprise a cutting member for cutting ahole in the stomach wall, an optical member for viewing in the area ofthe stomach. The fixation member could be adapted for suturing thedevice to the stomach wall, on the inside thereof, or for stapling thedevice to the stomach wall, on the inside thereof, or for invaginatingat least a part of the device in the stomach wall withstomach-to-stomach sutures, on the inside thereof, or for invaginatingat least a part of the device in the stomach wall withstomach-to-stomach staplers, on the inside thereof.

The instrument could further comprise a special holding device, whichcould comprise a special holding device adapted to hold the stomachusing vacuum or using mechanical holding members.

-   -   A stretching device, adapted to post-operatively be adjustable        and comprising at least one expandable section, wherein the        stretching device is adapted to be adjustable between a first        collapsed state and a second expanded state. In the first        collapsed state the expandable section is collapsed, and in the        second expanded state, the expandable section is expanded. The        outer surface of said expandable section does at least partly        comprise a surface structure having elevated areas alternating        with lowered areas. The expandable section is adapted to have,        in at least one of said first collapsed and second expanded        states a first distance between adjacent elevated areas        sufficiently extended to prevent growth of fibrotic tissue from        directly interconnecting adjacent elevated areas to an extent        that compromises the adjustability between a first collapsed and        a second expanded state of said stretching device. The        expandable section further comprising connecting areas between        adjacent elevated and lowered areas, further adapted to have, in        at least one of said first collapsed and second expanded states,        a second distance between adjacent connecting areas sufficiently        extended to prevent growth of fibrotic tissue from directly        interconnecting adjacent connecting areas to an extent that        compromises the adjustability between a first collapsed and a        second expanded state of said stretching device.    -   According to one embodiment the expandable section is hollow or        comprises a hollow body.    -   According to another embodiment the stretching device is        substantially completely hollow or comprises a hollow body        extending along substantially the complete length and/or        complete volume of said stretching device.    -   Fibrotic tissue can often have an extension or thickness of        about 0.5 mm to about 1.5 mm and hence the distances between        relevant surfaces of the elements of the surface structure are        suitably greater than about 3 mm, hence greater than about        2×1.5 mm. But depending on the circumstances also distances        greater than about 1.0 mm to about 3 mm may be sufficient. In        cases where the fibrotic tissue can be expected to have an        extension or thickness greater than about 1.5 mm the distances        between relevant surfaces of the elements of the surface        structure are adapted in a suitable manner.    -   The surface structure may comprise elevated and lowered areas        and it may be suitable that also a distance between the        different planes of the elevated and lowered areas is bigger        than a certain threshold to facilitate the collapsible and/or        expandable functionality of the stretching device. If said        distance is too small, the collapsible and/or expandable        functionality of the stretching device may be limited. A        suitable interval for said distance is around 0.5 to 10 mm, more        suitable around 2-8 mm and most suitable around 3-7 mm The        surface structure may comprise different geometrical elements or        shapes and any combination of such elements or shapes as long as        the above mentioned conditions for the distances can be met. The        surface structure may e.g. comprise ridges and grooves of        different shapes. The ridges and grooves may each have a        cross-section that is e.g. wedge-shaped, polygonal,        square-formed, pyramidal-shaped, truncated pyramidal-shaped or.        Further may the ridges and grooves have cross-sections of        different shapes. The surface structure may as well in general        comprise a bellows-shaped structure or a surface structure where        geometrical objects of the same or different kind(s) are placed        on a surface. The geometrical objects may be practically        randomly placed on the surface or according to some scheme.    -   One type of stretching devices where this type of surface        structure may be suitable, is stretching devices where the        stretching device should have the ability to change shape and/or        size substantially. Hence, this is a case where the presence of        fibrotic tissue substantially could hinder or impede the        function of the stretching device. But the surface structure may        be used by any stretching device where the characteristics of        the surface structure would be advantageous for the stretching        device.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will now be described in more detail by way ofnon-limiting examples and with reference to the accompanying drawings,in which:

FIG. 1 shows a stretching device implanted in the stomach fundus wall ofa patient, on the inside thereof.

FIG. 2 a shows a stretching device implanted in the stomach fundus wallof a patient, on the outside thereof.

FIG. 2 b shows a stretching device implanted in the stomach fundus wallof a patient, on the outside thereof in a second state.

FIG. 3 a shows an embodiment where the stretching device comprises twostretching devices, according to a first embodiment.

FIG. 3 b shows an embodiment where the stretching device comprises twostretching devices, according to second embodiment.

FIGS. 4 a-i shows the stretching device according to differentembodiments.

FIG. 5 a is a sectional view of a surface structure 700 of thestretching device 10,

FIG. 5 b is a sectional view similar to that of FIG. 5 a but with aslightly different surface structure 700,

FIGS. 5 c-e are drawings showing sections of examples of the surfacestructure 700 described herein,

FIG. 5 f schematically shows an embodiment of a stretching device 10having a surface structure 700,

FIGS. 5 g and 5 h show examples of different cross sections for aprosthesis,

FIGS. 5 i-5 k are drawings showing examples of different surfacestructures.

FIGS. 6 a-c shows the stretching device invaginated in the stomach wall.

FIG. 7 shows an embodiment wherein the stretching device is a mechanicalstretching device, according to a first embodiment.

FIGS. 8 a-8 b show an embodiment wherein the stretching device is amechanical stretching device, according to a second embodiment.

FIG. 9 a shows an embodiment wherein the stretching device is amechanical stretching, device, according to a third embodiment.

FIG. 9 b shows a mesh adapted to assist in the fixation of thestretching device.

FIG. 9 c shows an embodiment wherein the stretching device is amechanical stretching device, according to a fourth embodiment.

FIG. 10 a shows an embodiment wherein the stretching device is amechanical stretching device, according to a fifth embodiment.

FIG. 10 b shows an embodiment wherein the stretching device is amechanical stretching device, according to a fifth embodiment, in,greater detail, in a first state.

FIG. 10 c shows an embodiment wherein the stretching device is amechanical stretching device, according to a fifth embodiment, ingreater detail, in a second state.

FIG. 11 a shows an embodiment where the stretching device is combinedwith a device for treating reflux decease, according to a firstembodiment.

FIG. 11 b shows an embodiment where the stretching device is combinedwith a device for treating reflux decease, according to a secondembodiment.

FIG. 12 a shows an embodiment where the stretching device is combinedwith a volume filling device.

FIG. 12 b shows yet another embodiment of the stretching device, in amanual version.

FIG. 12 c shows yet another embodiment of the stretching device, in anautomatic version.

FIGS. 13-36 c shows schematic figures describing different functions ofthe stretching device.

FIG. 37 a shows the control unit of a gastroscopic instrument.

FIG. 37 b shows the gastroscopic instrument when placed in the stomach.

FIG. 37 c shows the gastroscopic instrument when penetrating the stomachwall.

FIG. 37 d shows the gastroscopic instrument when penetrating the stomachwall, in greater detail.

FIG. 37 e shows a gastroscopic or laparoscopic instrument according toone embodiment.

FIG. 37 f shows a gastroscopic or laparoscopic instrument according toone embodiment, in a second state.

FIG. 37 g shows a gastroscopic or laparoscopic instrument according toone embodiment, in a third state.

FIG. 37 h shows a gastroscopic or laparoscopic instrument according toone embodiment, in a fourth state.

FIG. 37 i shows a gastroscopic or laparoscopic instrument according toone embodiment, in a fifth state.

FIG. 38 a-d shows a gastroscopic or laparoscopic instrument in greaterdetail.

FIG. 39 a-j shows a gastroscopic or laparoscopic instrument creating acavity or pocket in the stomach wall and inserting a stretching device.

FIG. 40 a-f shows a gastroscopic or laparoscopic instrument creating acavity or pocket in the stomach wall and inserting a stretching device.

FIG. 41 a,b shows a gastroscopic or laparoscopic instrument inserting aguiding wire.

FIG. 42 shows a flowchart of a gastroscopic method,

FIG. 43 shows a flowchart of a laparoscopic or surgical method.

DETAILED DESCRIPTION

Invaginated in the stomach wall is to be understood as an object beingplaced inside of a cavity made of stomach wall material. Theinvagination enables stomach to stomach sutures or staplers whichenables the object of be enclosed by means of the human tissue healing.

In the following a detailed description of embodiments will be given. Inthe drawing figures, like reference numerals designate identical orcorresponding elements throughout the several figures. It will beappreciated that these figures are for illustration only and are not inany way restricting the scope. Thus, any references to direction, suchas “up” or “down”, are only referring to the directions shown in thefigures. Also, any dimensions etc. shown in the figures are forillustration purposes.

-   -   FIG. 1 shows a first embodiment of an obesity treatment device.        The device comprises a stretching device 10 implanted in a human        patient. In FIG. 1 the stretching device 10 is invaginated in        the wall 12 of the patient's stomach 12 and the body of the        stretching device 10 is shaped to rest against the wall 12 of        the stomach 12 and further has an outer surface suitable to rest        against this wall 12. This means that the stretching device 10        preferably has an essentially round shape to not damage the        stomach wall. However, the stomach wall 12 is strong so many        different shapes and forms may be used.    -   The stretching device 10 can be fixed to the wall 12 a of the        stomach 12 in a number of different ways. In the embodiment        shown in FIG. 1 , the stretching device 10 is invaginated in the        stomach wall 12 a. After in-vagination, a number of        stomach-to-stomach sutures or staplers 14 are applied to keep        the in-vagination in the short term. This allows growth of human        tissue, keeping the in-vagination in the long term.    -   By enlarging the size of the stretching device, the stomach wall        12 surrounding the stretching device 10 is stretched since the        circumference of the stretching device 10 is increased. By this        stretching, receptors in the stomach wall indicate that the        stomach is full, thereby creating a feeling of satiety to the        patient. Correspondingly, when the stretching device 10 is        contracted, the receptors indicate that the stomach is not full,        thereby returning the feeling of hunger.    -   The expansion and contraction of the stretching device 10 can be        performed under direct control of the patient. Alternatively,        the expansion and contraction can be performed according to a        pre-programmed schedule.    -   Returning to FIG. 1 , this figure also shows a fluid operation        device, i.e., a hydraulic or pneumatic operation device suited        for operating the stretching device, which in the following will        be described in detail.    -   The stretching device 10 forms a fluid chamber, in which fluid        is allowed to flow. The stretching device 10 thus forms an        expandable chamber that can change the volume it occupies in the        stomach wall, thereby forming a hydraulically or pneumatically        regulated stretching device 10.    -   A regulation reservoir 16 for fluids is connected to the        stretching device 10 by means of a conduit 18 in the form of a        tube. The stretching device 10 is thereby adapted to be        regulated, preferably non-invasively, by moving liquid or air        from the regulation reservoir 16 to the chamber formed by the        stretching device.    -   The regulation reservoir 16 can be regulated in several ways. In        the embodiment shown in FIG. 1 , the regulation reservoir 16 is        regulated by manually pressing the regulation reservoir 16. In        other words, the regulation reservoir 16 is regulated by moving        a wall of the reservoir. It is then preferred that the        regulation reservoir 16 is placed subcutaneously and        non-invasive regulation is thereby achieved.    -   When the regulation reservoir 16 is pressed, the volume thereof        decreases and hydraulic fluid is moved from the reservoir to the        chamber formed by the stretching device 10 via the conduit 18,        enlarging or expanding the stretching device 10. For filling and        calibrating the fluid level of the device an injection 1001 port        is furthermore provided. The injection port preferably comprises        self sealing membrane, such as a silicone membrane.    -   It will be appreciated that instead of hydraulic operation,        pneumatic operation can be used, wherein air instead of        hydraulic fluid is moved between the reservoir 16 and the        chamber formed by the stretching device 10. Preferable the        reservoir has a locking position to keep it in the desired        position. If the patient compresses the reservoir 16 it        preferably stays compressed and releases after pressing again.    -   Any kind of hydraulic solution may be used for the stretching        device. The hydraulic solution may be driven by both        mechanically and be powered with any motor or pump as well as        manually.    -   FIG. 1 further shows a reversed servo system which comprises a        regulation reservoir 16 and a servo reservoir 90. The servo        reservoir 90 hydraulically controls a stretching device 10 via a        conduit 18. The reverse servo function is described in greater        detail in FIGS. 33-36    -   FIG. 2 a shows the device according to another embodiment in        which a motor 40 is adapted to move a wall of the regulation        reservoir 16. The powered regulation reservoir 16 is then        preferably placed in the abdomen of the patient. In this        embodiment, a wireless external remote control unit 34 b,c and        an external energy transmission device 34 a can be provided to        perform non-invasive regulation of the motor via an energy        transforming device 30, which is adapted to supply an energy        consuming operation device, in the present example the motor 40,        with energy.    -   The remote control may comprise a wireless energy transmitter,        34 a which also can act as a regulation device for        non-invasively regulating the stretching device. When the        regulation is performed by means of a remote control 34 an        internal power source 70 for powering the regulating device is        provided. The internal energy source 70 can for example be a        chargeable implanted battery or a capacitor or a device for        receiving wireless energy transmitted from outside the body of        the patient. Different ways of regulating the stretching device        10 will be described below with reference to FIGS. 13-29 .    -   The device as shown in FIG. 2 a further comprises a sensor 201        sensing a parameter of the patient or the device preferably        connected to the food intake of the patient. The sensor is        connected to a control assembly 42 by means of a sensor signal        transferring member 202. The sensor can be used to regulate said        device in a completely automatic way, i.e. the device responds        to a sensor signal connected to the food intake of the patient,        thereby affecting the control assembly to operate the stretching        device 10 to stretch the stomach wall 12 and thereby creating a        feeling of satiety in the patient. The sensor could be adapted        to measure the food intake of the patient through any of        temperature, blood pressure, blood flow, heartbeats, breathing        and pressure and can be placed in the stomach 12, esophagus 203        or in connection with the cardia 204. According to one        embodiment said sensor is a strain gauge measuring contraction        and/or relaxation of the cardia 204.    -   The device as shown in FIG. 2 a further comprises a second        conduit 222 for backflow of hydraulic fluid. The backflow is        adapted to create the desired feeling of satiety for a        predetermined time whereafter the hydraulic fluid has flowed        back in a quantity large enough for the stretching device not to        stretch the stomach wall anymore and thereby the feeling of        hunger returns to the patient. A suitable time for the process        is between 1 and 6 hours. According to other embodiments the        backflow takes place in the main conduit 18 by means of a valve        system connected to said conduit 18.    -   For filling and calibrating the fluid level of the device an        injection 1001 port is furthermore provided. The injection port        1001 preferably comprises self sealing membrane, such as a        silicone membrane.    -   FIG. 2 b shows the device according to the embodiment of FIG. 2        a , in a second state in which the stretching device 10 is        expanded and thereby stretches the stomach wall 12.    -   FIG. 3 a shows an embodiment, wherein two stretching devices 10″        are provided. Both stretching devices 10″ work according to the        principles described above with reference to FIG. 1 . They can        be adapted to postoperatively and non-invasively be regulated        and adapted to from time to time regulate different stretching        devices to at a first time stretch a first part of the stomach        wall and at a second time stretch a second part of the stomach        wall.    -   Such a stretching device 10 may be used for keeping electronics        and/or an energy source and/or hydraulic fluid. Hydraulic fluid        from that device may be distributed to several smaller        stretching device areas to vary the stretching area from time to        time avoiding any possible more permanent stretching effect of        the stomach wall. Even mechanically several stretching areas may        be used. The embodiment according to FIG. 3 a further comprises        a hydraulic valve shifting device 54, implanted in the patient,        for shifting between operating the first and the second        stretching device 10″. The alternating creates a more        sustainable device since the receptors in the stomach wall is        stimulated gets a longer time of recovery between the stretches.    -   In FIG. 3 a the system is a manual system controlled by the        patient as described before with reference to FIG. 1 , whereas        in FIG. 3 b the system is energized using wireless energy as        described before with reference to FIG. 2 a.    -   FIG. 4 a-e shows different embodiments of the stretching device        10 adapted to be implanted in a patient. The stretching device        10 comprises a surface adapted to be in contact with the stomach        wall 12 when the device is invaginated in the stomach wall. FIG.        4 b shows an embodiment of the stretching device in which the        stretching device comprises a fixating member 206 for suturing        or stapling the stretching device to the stomach wall. The        fixating member 206 could comprise holes for receiving said        sutures or staplers 14, or the fixation device 206 could be        penetratable such that the sutures or staplers can penetrate the        stomach wall and the fixation device 206. 4 c shows the        stretching device 10 according to an embodiment in which the        stretching device 10 comprises an inlet member 207 for filling        said device with a fluid. Said inlet member is preferably        connected to a hydraulic conduit 18 adapted to be invaginated in        the stomach wall 12. FIG. 4 d shows the stretching device 10        according to an embodiment in which the stretching device 10        comprises a holding member 208 adapted to connect to an        insertion device when said stretching device 10 is inserted into        an invaginated pouch of the stomach wall 12. FIG. 4 e shows the        stretching device 10 according to an embodiment in which the        stretching device has a slightly oval or egg-shaped shape. FIG.        4 e furthermore shows the hydraulic conduit 18 attached to said        stretching device 10. FIG. 4 f shows the stretching device 10        according to an embodiment in which the stretching device is        inflatable by a fluid transported through the conduit 18.        According to one embodiment shown in FIG. 4 f the conduit        comprises two sections 18 a,b wherein the first section 18 a is        used to pull the stretching device 10 into place, and to fill        the device 10 with a suitable fluid, whereas the second section        18 b is used for the operation of said device 10. FIG. 4 g shows        the stretching device 10 according to the embodiment of FIG. 4 f        in a deflated state. The stretching device 10 is inserted        through a hole in the stomach wall 12 in its deflated state        whereafter the device 10 is filled with a suitable fluid for        operation. FIG. 4 h shows the stretching device 10 according to        an embodiment in which the stretching device 10 comprises two        movable wall portion 223 a,b, which are moveable by means of a        bellows structure 209 made of a flexible material. FIG. 4 i        shows the stretching device according to an embodiment where the        stretching device is expandable by means of four expandable        sections 210 symmetrically placed on four places along the        surface of the stretching device, as shown in the section image        of FIG. 4 i . The expandable sections 210 are made of a flexible        material for allowing said sections 210 to expand when said        stretching device 10 is filled with a hydraulic fluid.    -   A first distance 708 a between two elevated areas 701, see FIG.        5 a , is long enough so as to prevent growth of fibrotic tissue        directly connecting two adjacent elevated areas 707. That is, it        may be possible that fibrotic tissue grows on the surface of the        elevated and lowered areas 701, 702 and the connecting areas        704. However, thanks to the extension of the first distance 708        a, fibrotic tissue is prevented from growing directly from one        elevated area 701 to another adjacent elevated area 701.    -   With the expression “growing directly from one elevated area 701        to another elevated area 701” it is e.g. meant that fibrotic        tissue grows from one elevated area 701 to another while not or        only to a small extent growing on a connecting area 704. As        indicated at 704 a in FIG. 5 i , the first distance 708 a may be        measured within an interval 704 a from the level of an elevated        area 701. The expression “growing directly from one elevated        area 701 to another elevated area 701” also includes the        situation that fibrotic tissue grows on adjacent areas, e.g. two        adjacent connecting areas 704, with such a thickness that the        fibrotic tissue from each adjacent area meet and bridge the        distance or space between two elevated areas 701. In such a        situation the space between two elevated areas 701 may be partly        or completely filled with fibrotic tissue.    -   It may be advantageous that also a second distance 708 b        corresponding to the extension of a lowered area 702 has an        extension great enough so as to prevent fibrotic tissue from        growing directly from one connecting area 704 to another        connecting area 704. With the expression “growing directly from        one connecting area 704 to another connecting area 704” it is        meant that fibrotic tissue grows from one connecting area 704 to        another while not or only to a small extent growing on a lowered        area 702.    -   In FIG. 5 a surface structure comprising elevated and lowered        areas has been shown, but apart from elevated and lowered areas        also many other geometrical structures may be used where it is        possible to fulfill the above mentioned prevention of growth of        fibrotic tissue. In particular, the above mentioned prevention        of growth of fibrotic tissue between elevated areas and between        connecting areas.    -   Some examples of such other geometrical structures are shown in        FIGS. 5 i-5 k . In a surface structure comprising ridges and        grooves, the ridges and grooves may also have different        sections, some examples are shown in FIGS. 5 a -5 e.    -   Referring mainly to FIGS. 5 a and 5 b some expressions and        aspects will now be explained. In this application the concept        of a first distance 708 a, 718 a between adjacent elevated areas        701, 710 is used. With such a first distance 708 a, 718 a it is        meant a distance that is measured substantially from the edge        706, 714 of one elevated area 701, 710 to the edge 706, 714 of        an adjacent elevated area 701, 710. Measured substantially from        the edge means that the measurement may be done within a first        interval 704 a from the level of an elevated area 701, 710, the        first interval 704 a extending from the level of an elevated        area 701, 710 towards the level of an adjacent lowered area 702,        712.    -   In this application also the concept of a second distance 708 b,        718 b between adjacent connecting areas 704, 716 is used. With        such a second distance 708 b, 718 b it is meant a distance that        is measured substantially from the connection point between a        connecting area 704, 716 and a lowered area 702, 712 to another        connection point involving an adjacent connecting area 704, 716.        Measured substantially from the connection point means that the        measurement may be done within a second interval 704 b from the        level of a lowered area 702, 712, the second interval 704 b        extending from the level of a lowered area 702, towards the        level of an adjacent elevated area 701, 710.    -   With elevated and lowered areas it is meant areas that lie in        different planes 703, 705, 720, 722 where the planes are        separated by a distance 707, 724, 728. The planes may be        parallel or substantially parallel but may also be non-parallel.        If the planes are parallel, defining a distance between them is        trivial. If the planes are non-parallel (as in FIG. 5 b ) a        distance between the planes may be defined by a normal 724, 728        to one of the planes 720, 722 where the normal extend to a point        on an area in another plane 722, 726 and the distance between        the planes is equal to the extension of the normal 724, 728. As        seen in FIG. 5 b the normal 724, 728 extends from a plane 720,        722 to a point which is approximately equally distant from the        edges of an area. There are two possible ways to define the        normal or distance between the planes. Taking normal 728 as        example, one may define the normal as in 728 a or in 728 b. It        may be suitable to define the distance between two planes as the        extension of the longest normal, the distance between the planes        720 and 722 would then be equal to the extension of normal 728        a. This definition will be used hereafter.    -   The elevated and lowered areas may have different shapes, they        may be plane or substantially plane but they may also have some        kind of curved shape.    -   The elevated areas 701, 710 connect to adjacent lowered areas        702, 712 by means of connecting areas 704, 716. The connection        between elevated/lowered areas and connecting areas 704, 716 may        comprise a radius of different sizes, bigger or smaller radii.        When the radius is very small there will substantially be an        edge 706, 714 connecting the areas.    -   The expression “expandable section” implies that said section        also is collapsible.    -   Suitably the stretching device 10 at least partly comprises        materials which have a high degree of biocompatibility, such        materials may be called physiologically inert, biologically        inert or biocompatible.    -   Referring in particular to FIGS. 5 a and 5 b , in the surface        structure 700 there may advantageously be a specified first        distance 708 a, 718 a between adjacent elevated areas 701, 710.        The distance between adjacent elevated areas 701, 710 is chosen        so that fibrotic tissue cannot bridge the first distance 708 a,        718 a between adjacent elevated areas 701, 710. Hence, the first        distance 708 a, 718 a between adjacent elevated areas 701, 710        is advantageously big enough to prevent the formation of        fibrotic tissue that bridges adjacent elevated areas 701, 710.    -   As mentioned before, there may advantageously be a specified        second distance 708 b, 718 b between adjacent connecting areas        704, 716. The second distance 708 b, 718 b between adjacent        connecting areas 704, 716 is chosen so that fibrotic tissue can        not bridge the second distance 708 b, 718 b between adjacent        connecting areas 704, 716. Hence, the second distance 708 b, 718        b between adjacent connecting areas 704, 716 is advantageously        big enough to prevent the formation of fibrotic tissue that        bridges adjacent connecting areas 704, 716.    -   It may also be advantageous that a third distance 707, 724, 728        a between the different planes 703, 705, 720, 722, 726 of the        elevated and lowered areas is bigger than a certain threshold to        facilitate the collapsible and/or expandable functionality of        the stretching device. If the third distance 707, 724, 728 a is        too small the collapsible and/or expandable functionality of the        stretching device may be limited. A suitable interval for the        third distance 707, 724, 728 a is 0.5 to 10 mm, more suitable        2-8 mm and most suitable 3-7 mm. Also regarding the aspect that        the fibrotic tissue should not impede the collapsible/expandable        functionality of the stretching device it is advantageous that        the distance 707, 724, 728 a is not too small, but suitably in        the interval/s as mentioned previously.    -   The surface structure 700 may include objects or elements of        different geometrical shapes, for example ridges of different        shapes, embossments of different shapes and other objects which        enable a surface structure as described herein. The area of the        elevated areas 701, 710 may be very small while still resulting        in a surface structure that has the desired functionality. The        area of the elevated areas 701, 710 may even be almost zero, as        exemplified in FIG. 5 e . Whereas FIGS. 5 a and 5 b-5 e show        cross sections of examples of surface structures 700, FIGS. 5        i-5 k show examples of different surface structures 700 in        perspective. The objects or elements in the surface structure        700 may be placed in rows, ordered in some other way, or may be        more or less randomly distributed over the surface of the        stretching device. Different types of objects may also be used        together in the surface structure 700, e.g. a combination of        pyramid shaped and cone shaped objects together with ridges of        some shape.    -   In FIGS. 5 f-5 h an embodiment of a stretching device 10 is        shown where a surface structure 700 is used, the stretching        device 10 is not shown in full. FIG. 3 shows a longitudinal        section of the stretching device 10 where 740 denotes the        surface structure on the upper side of the stretching device 10        and 742 denotes the surface structure on the under side of the        stretching device 10. As shown in FIG. 5 f the surface structure        742 on the under side may have a greater extension than the        surface structure 740 on the upper side of the penile        prosthesis. This gives the stretching device 10 an up-bent        position when the stretching device 10 is expanded. The surface        structures 140 and 142 are one example of a bending portion.        FIG. 5 g shows a cross section of the stretching device 10 where        the stretching device 10 includes a waist portion 744, where the        waist portion comprises waist surface structures 746 and 748.        The waist portion with the waist surface structures 746 and 748        make the stretching device 10 expandable also in the radial        direction. The stretching device 10 may also have a cross        section as shown in FIG. 10 comprising a waist portion 744        having four waist surface structures 750, 752, 754, 756 further        facilitating the ability of the stretching device 10 to be        expandable also in the radial direction. The cross section in        FIG. 5 g is taken along the line A1-A2 in FIG. 5 f.    -   FIG. 6 a illustrates a stretching device 10 provided with an        inlet port 18 b. The stretching device 10 is invaginated in the        stomach wall 12 and the inlet port 18 b is available for        connection to a tube or the like from the abdominal area of the        patient. The tube or conduit 18 can preferably be connected to        the control unit 42 or an injection port 1001.    -   FIG. 6 b illustrates an invaginated stretching device 10        wherein, instead of an inlet port, a conduit 18 or electrical        lead extends into the abdominal area of the patient.    -   FIG. 6 c shows a section of the stretching device 10 and part of        the stomach in which the stretching device 10 is invaginated.        The conduit 18 or electric lead is invaginated in the stomach        wall 12 by means of stomach to stomach sutures or staplers 14        which creates an entirely sealed pouch of stomach wall tissue in        which the stretching device 10 is placed. The conduit 18 or        electric lead is thereby tunneled in the stomach wall 12 between        the inlet port 18 b and the volume filling device 10.    -   It has been shown that the shape of the stretching device 10 can        take many different forms. It will be appreciated that also the        material of the stretching device 10 can vary. It is preferred        that the stretching device 10 is provided with a coating, such        as a Parylene, polytetrafluoroethylene (PTFE), or polyurethane        coating, or a combination of such coatings, i.e., a multi-layer        coating. This coating or multi-layer coating improves the        properties of the stretching device, such as its resistance to        wear.    -   In another embodiment shown in FIG. 7 , the stretching device        110 works according to a different principle from that described        above with reference to FIGS. 1-6 . The stretching device 110        here comprises a first fixation portion 110 a adapted to have a        first fixation at a first position on the stomach wall 12 and a        second fixation portion 110 b adapted to have a second fixation        at a second position on the stomach wall 12. These fixation        portions 110 a,b, which preferably have an essentially round        shape and preferably are adapted to be invaginated in the        stomach wall 12, are attached to the distal end of a respective        leg 211, which in turn are attached at their respective proximal        end to an operation device, such as a motor 40. According to the        embodiment shown in FIG. 7 the motor is a hydraulic motor,        comprising a hydraulic piston, which is connected to a manual        operation device described previously with reference to FIG. 1 .        The hydraulic piston affects the legs through their connection        with a joint 212 placed in the extremity of the leg. The        stretching device 110 is enclosed in a housing 214 protecting        the device from the in growth of fibrotic tissue which        potentially could damage the function of said device 110.        However it is equally conceivable that the motor is another        hydraulic motor, a pneumatic motor or an electrical motor.    -   The stretching device 110 is adapted to increase the distance        between the first position and the second position on the        stomach wall 12, thereby stretching the stomach wall 12. The        first and/or second fixation portions 110 a, 110 b are adapted        to at least partly be invaginated in the stomach wall 12 with        stomach-to-stomach sutures or staplers 14 holding the fixation        portions 110 a,b in place in suspension in relation to the        stomach wall 12.    -   Of course the first and second positions may be sutured or        fixated to the stomach wall in many possible ways and the        invention covers all possibilities to distend the stomach wall        by moving two portions of the stomach wall away from each other        and thereby first fixating the device to at least two positions        on the stomach wall. However, the soft suspended connection to        the stomach wall 12 where fibrotic stomach-to-stomach tissue        helps to give a long term stable position is to prefer.    -   Of course just expanding an invaginated part of the stomach also        stretches away the stomach wall 12, which also may be achieved        both mechanically, hydraulically, pneumatically and both being        powered with a motor or pump or by manual force.    -   Any kind of mechanical construction may be used and the        mechanical embodiment disclosed is one example. Any mechanical        construction driven by mechanically or hydraulically or any        pneumatic construction may be used. Any motor or any pump or        moving material changing form when powered may be used to        achieve the simple goal of stretching a part of the stomach wall        by moving at least two portions of the stomach wall away from        each other.    -   FIGS. 8 a-8 h show the stretching device 110 according to an        embodiment in which the stretching device is controlled from an        implantable control assembly 42 to which sensor input, as        described earlier, in received. The stretching device is then        regulated through the conduit 18 using a pump 44, connected to        at least one fluid reservoir 16, 46, and powered from a energy        transforming member 30 connected to an receiver of wireless        energy 205, placed under the skin 36, or an implantable energy        source 70, such as a rechargeable battery.    -   In a variant, shown in FIG. 9 a , the first and/or second        fixation portions 210 a, 210 b, respectively, exhibit a        structure adapted to be in contact with the stomach wall 12 to        promote growth in of human tissue to secure the long term        placement of the stretching device 110 attached to the stomach        wall 12. This structure preferably comprises a net like        structure 213. The fixation portions 210 a, 210 b may be adapted        to keep the stretching device 110 in place by sutures or        staplers between the fixation portion and the stomach wall 12 to        secure the short term placement of the stretching device 110. In        turns of mechanical operation the stretching device 110        according to the embodiment shown in FIG. 9 a functions in        accordance with the device described with reference to FIG. 7 .        FIG. 9 b shows a fixation device 213 comprising a net like        structure adapted to propagate the growth-in of fibrotic tissue        to fixate the two fixating portions to the stomach wall 12.    -   FIG. 9 c shows the stretching device according to the embodiment        of FIG. 9 a in a second state, in which the two fixating        portions have been separated from each other and the stomach 12        has been stretched.    -   FIG. 10 a shows the stretching device according to an embodiment        in which the stretching device is an electrical mechanical        stretching device connected to a control assembly 42 through a        power supply line 32′. The power supply line 32 is connected to        a power transforming device 30 in contact with a receiver of        wireless energy 205, such as a coil, which receives energy from        a transmitter of wireless energy 34 a. The control assembly may        furthermore comprise a battery 70 for storing energy received        from the wireless energy transmission device 34 a. The control        assembly receives input from a sensor 201, which according to        this embodiment is a strain gauge measuring the contraction        and/or relaxation of the cardia 204.    -   FIG. 10 b shows the stretching device 10 in further detail. The        stretching device 10 comprises a housing having a bellows        structure 209 made of a flexible material so as to enable the        wall portions to move. The power supply line 32 is connected to        a stator 217 of an electrical motor, said motor further        comprising a rotor 218 which comprises a thread that interacts        with a displaceable member 219 comprising a corresponding        thread. The displacing member is rotatably fixated to a housing        contacting member 220 which pushes against the housing for        affecting the volume of the stretching device and thereby        stretching the stomach 12.    -   FIG. 10 c shows the stretching device according to FIG. 10 b in        a second state, in which the stretching device is expanded and        thereby stretches the stomach wall 12.    -   FIG. 11 a shows an embodiment in which a device adapted to treat        reflux disease is combined with the stretching device according        to any of the embodiments above. After invagination of the        device 410 in the fundus 416, a fixation consisting of a number        of stomach-to-stomach sutures or staples 422 a is applied to        keep the invagination intact in the short term. A second        fixation consisting of a number of sutures or staples 422 b is        provided to hold the device 410 in position above the cardia        414. The sutures or staples 422 b are applied between the wall        of the fundus 416 and the wall of the esophagus 424.        Additionally, a third fixation in the form of sutures or staples        422 c may be provided between the wall of the fundus 416 and the        diaphragm 418, again, to hold the device 410 in position above        the cardia 414.    -   In this fourth embodiment depicted in FIG. 11 a , the size of        the reflux disease treatment device 410 can be regulated while        being implanted. The reflux disease treatment device 410 is        associated with a subcutaneous hydraulic reservoir 452 connected        to the reflux disease treatment device 410, by a lead 452 b        whereby a non-invasive regulation can be performed by manually        pressing the reservoir 452. Pressing the reservoir 452 displaces        hydraulic fluid from the reservoir 452 to the smaller chambers        410 b via the lead 452 b. The reflux disease treatment device        410 is, in turn, connected to one or more smaller chambers 410        b. In this manner, the patient may adjust the size of the reflux        treatment device 410 in a manner adapted to the treatment.    -   Furthermore, the embodiment above may alternatively be used to        also treat obesity. The device may, in this embodiment, be        adapted to treat obesity by using the volume of the reflux        disease body to contain a fluid, and further using one or        several smaller chambers 410 b connected to the device body with        a pump to be filled with fluid to expand and thereby stretch the        fundus wall to create satiety. The small chambers 410 b are also        adapted to be invaginated to in the fundus stomach wall, and        when filled with fluid, an expansion of the stomach occurs that        results in human sensor feedback creating satiety. The        subcutaneous hydraulic reservoir/pump enables the patient to        conveniently pump hydraulic fluid to fill the small chambers 410        b to create a feeling of satiety as he or she wishes.    -   An alternative embodiment is shown in FIG. 11 b . This        embodiment is substantially similar to the one shown in FIG. 11        a but differs in how the reflux treatment device 410 and        chambers 410 b are controlled. Here, the chambers 410 b are not        controlled by a subcutaneous pump but a powered internal control        unit 456. The internal control unit 456 comprises means for the        patient to control the device 410 in how it shall be used        regarding treatment of reflux and/or obesity. It may also        comprise means of supplying power to the device.

The internal control unit 456 may comprise a battery 470, an electricswitch 472, a motor/pump 444, a reservoir 452, an injection port 1001.An energy transmission device 34 with a remote control is adapted forcontrolling and powering the device. The items being selected dependingon the circumstances, e.g. if the device is electrically, hydraulically,pneumatically or mechanically operated.

-   -   The device 410 may be used for keeping electronics and/or an        energy source and/or hydraulic fluid.    -   FIG. 12 a shows an adjustable volume filling device 810, which        is invaginated in the stomach wall of a patient's stomach 12.        The volume filling device 810 is adapted to take up space in the        stomach and thereby reduce the volume in which food can be        placed. Additionally, an adjustable stretching device 10        according to any of the embodiments is invaginated in the        stomach fundus wall of the patient. It is preferred that the        volume filling device 810 is substantially larger than the        stretching device 10.    -   The volume filling device 810 and the stretching device 10 are        in fluid communication with each other via a first fluid tube        52, in which a pump 54 is provided. The pump 54 is under the        control from an energy transforming device 30, which is adapted        to supply the pump 54 with energy via a power supply line 56.        The energy transforming device 30 is also connected to a sensor        201 provided in the esophagus of the patient so that food intake        can be detected.    -   The volume filling device 810 and the stretching device 10 are        also in fluid communication with each other via a second fluid        tube 58, which preferably has a smaller cross-sectional area        than the first fluid tube 52.    -   The operation of this arrangement is as follows. The volume        filling device 810 functions as in the above described        embodiments, i.e., it reduces the size of the food cavity of the        patient's stomach 12. Additionally, when the stretching device        10 is enlarged by pumping fluid from the volume filling device        810 and to the stretching device 10 by means of the pump 54, the        stomach fundus wall is stretched, creating a feeling of satiety        for the patient. Thus, for example when food intake is detected        by means of the sensor 201, fluid is automatically pumped into        the stretching device 10 to increase the feeling of satiety and        thereby limit the food intake.    -   When fluid has been injected into the stretching device 10, the        internal pressure therein is higher than the internal pressure        in the volume filling device 810. This difference in pressure        will create a flow of fluid in the second, preferably narrower        tube 58 from the stretching device 10 to the volume filling        device 810. The flow rate will be determined by among other        things the difference in pressure and the cross-sectional area        of the second tube 58. It is preferred that the second tube is        so dimensioned, that the pressures in the volume filling device        810 and the stretching device 10 will return to equilibrium        after 3 hours after fluid has been injected into the stretching        device 10 to create the feeling of satiety.    -   In this embodiment, the function of the second tube 58 is to        allow fluid to return from the stretching device 10 to the        volume filling device 810. It will be appreciated that this        function also can be performed by the pump 54 in the first tube        52 and that the second tube 58 then can be omitted.    -   Yet an alternative embodiment of a device for treating obesity        will now be described with reference to FIG. 12 b , which shows        a stomach 12 of a patient who is treated for obesity. The device        comprises a volume filling device 810 in the form of an        inflatable device 10 which is invaginated in the wall 12 a of        the patient's stomach 12. However, in this case the invagination        has been performed in the fundus, i.e., the upper portion of the        stomach, where the number of receptors in the stomach wall is        large, and the inflatable device functions as a stretching        device for part of the stomach fundus wall.    -   A regulation reservoir for fluids is connected to the inflatable        device by means of a conduit 18 in the form of a tube. The        inflatable device 810 is thereby adapted to be regulated,        preferably non-invasively, by moving liquid or air from the        regulation reservoir to the chamber formed by the inflatable        device 810. The regulation of the inflatable device 810        preferably comprises a reversed servo, i.e., a small volume is        actuated for example by the patient's finger and this small        volume is in connection with a larger volume, i.e., the        regulation reservoir.    -   Thus, the inflatable device 810 is placed outside the stomach        wall and is adapted to stretch a part of the stomach fundus        wall, thereby affecting the patient's appetite. By enlarging the        size of the stretching device, the stomach fundus wall        surrounding the inflatable stretching device 810 is stretched        since the circumference of the inflatable stretching device 810        is increased. By this stretching, the receptors in the stomach        wall indicate that the stomach is full, thereby creating a        feeling of satiety to the patient. Correspondingly, when the        stretching device 810 is contracted, the receptors indicate that        the stomach is not full, thereby returning the feeling of        hunger. It will be appreciated that this embodiment combines the        effects of both reducing the volume of the stomach food cavity        and stretching part of the stomach wall 12, thereby increasing        the treatment effect.    -   The expansion and contraction of the stretching device 810 can        be performed under direct control of the patient. Alternatively,        the expansion and contraction can be performed according to a        pre-programmed schedule.    -   In a preferred embodiment, shown in FIG. 12 c , a sensor 201 is        provided at a suitable position, such as at the esophagus. The        volume filling device 810 in the form of the inflatable        stretching device is similar to the one shown in FIG. 12 b . By        providing one or more sensors, the device for treating obesity        can be automated in that the size of the volume filling device        810 in the form of the inflatable stretching device is adjusted        depending on the amount of food entering the food cavity of the        stomach. The fluid is thereby moved between the inflatable        volume filling device 810 and a fluid reservoir.

System

-   -   A obesity treatment system, generally designated 28 and        comprising a stretching device as described above will now be        described with reference to FIGS. 13-29    -   The system of FIG. 8 comprises a stretching device 10 placed in        the abdomen of the patient. An internal energy source in the        form of an implanted energy transforming device 30 is adapted to        supply energy consuming components of the obesity treatment        system with energy via a power supply line 32. An external        energy transmission device 34 includes a wireless remote control        transmitting a wireless signal, which is received by a signal        receiver, which may be incorporated in the implanted energy        transforming device 30 or be separated therefrom. The implanted        energy transforming device 30 transforms energy from the signal        into electric energy which is supplied via the power supply line        32.    -   The system of FIG. 8 is shown in a more generalized block        diagram form in FIG. 15 , wherein the patient's skin 36,        generally shown by a vertical line, separates the interior of        the patient to the right of the line from the exterior to the        left of the line.    -   FIG. 13 shows a simplified block diagram showing the stretching        device 10, the energy transforming device 30 powering the        stretching device via power supply line 32, and the external        energy transmission device 34.    -   FIG. 14 shows an embodiment of the invention identical to that        of FIG. 17 , except that a reversing device in the form of an        electric switch 38 operable by polarized energy also is        implanted in the patient for reversing the stretching device 10.        The wireless remote control of the external energy transmission        device 34 transmits a wireless signal that carries polarized        energy and the implanted energy transforming device 30        transforms the wireless polarized energy into a polarized        current for operating the electric switch 38. When the polarity        of the current is shifted by the implanted energy transforming        device 30 the electric switch 38 reverses the function performed        by the stretching device 10.    -   FIG. 15 shows an embodiment of the invention identical to that        of FIG. 13 , except that an operation device 40 implanted in the        patient for regulating the stretching device 10 is provided        between the implanted energy transforming device 30 and the        stretching device 10. This operation device can be in the form        of a motor 40, such as an electric servomotor. The motor 40 is        powered with energy from the implanted energy transforming        device 30, as the remote control of the external energy        transmission device 34 transmits a wireless signal to the        receiver of the implanted energy transforming device 30.    -   FIG. 16 shows an embodiment of the invention identical to that        of FIG. 17 , except that it also comprises an operation device        is in the form of an assembly 42 including a motor/pump unit 78        and a fluid reservoir 46 is implanted in the patient. In this        case the stretching device 10 is hydraulically operated, i.e.        hydraulic fluid is pumped by the motor/pump unit 44 from the        fluid reservoir 46 through a conduit 48 to the stretching device        10 to operate the stretching device, and hydraulic fluid is        pumped by the motor/pump unit 44 back from the stretching device        10 to the fluid reservoir 46 to return the stretching device to        a starting position. The implanted energy transforming device 30        transforms wireless energy into a current, for example a        polarized current, for powering the motor/pump unit 44 via an        electric power supply line 50.    -   Instead of a hydraulically operated stretching device 10, it is        also envisaged that the operation device comprises a pneumatic        operation device. In this case, pressurized air can be used for        regulation and the fluid reservoir is replaced by an air chamber        and the fluid is replaced by air.    -   In all of these embodiments the energy transforming device 30        may include a rechargeable accumulator like a battery or a        capacitor to be charged by the wireless energy and supplies        energy for any energy consuming part of the device.    -   The external energy transmission device 34 is preferably        wireless and may include a remotely controlled control device        for controlling the device from outside the human body.    -   Such a control device may include a wireless remote control as        well as a manual control of any implanted part to make contact        with by the patient's hand most likely indirect for example a        button to press placed under the skin.    -   FIG. 17 shows an embodiment of the invention comprising the        external energy transmission device 34 with its wireless remote        control, the stretching device 10, in this case hydraulically        operated, and the implanted energy transforming device 30, and        further comprising a hydraulic fluid reservoir 52, a motor/pump        unit 44 and an reversing device in the form of a hydraulic valve        shifting device 54, all implanted in the patient. Of course the        hydraulic operation could easily be performed by just changing        the pumping direction and the hydraulic valve may therefore be        omitted. The remote control may be a device separated from the        external energy transmission or included in the same. The motor        of the motor/pump unit 44 is an electric motor. In response to a        control signal from the wireless remote control of the external        energy transmission device 34, the implanted energy transforming        device 30 powers the motor/pump unit 44 with energy from the        energy carried by the control signal, whereby the motor/pump        unit 44 distributes hydraulic fluid between the hydraulic fluid        reservoir 52 and the stretching device 10. The remote control of        the external energy transmission device 34 controls the        hydraulic valve shifting device 54 to shift the hydraulic fluid        flow direction between one direction in which the fluid is        pumped by the motor/pump unit 44 from the hydraulic fluid        reservoir 52 to the stretching device 10 to operate the        stretching device, and another opposite direction in which the        fluid is pumped by the motor/pump unit 44 back from the        stretching device 10 to the hydraulic fluid reservoir 52 to        return the stretching device to a starting position.    -   FIG. 18 shows an embodiment of the invention identical to that        of FIG. 17 , except that an internal control unit 56 controlled        by the wireless remote control of the external energy        transmission device 34, an accumulator 58 and a capacitor 60        also are implanted in the patient. The internal control unit 56        arranges storage of electric energy received from the implanted        energy transforming device 30 in the accumulator 58, which        supplies energy to the stretching device 10. In response to a        control signal from the wireless remote control of the external        energy transmission device 34, the internal control unit 56        either releases electric energy from the accumulator 58 and        transforms the released energy via power lines 62 and 64, or        directly transforms electric energy from the implanted energy        transforming device 30 via a power line 66, the capacitor 60,        which stabilizes the electric current, a power line 68 and the        power line 64, for the operation of the stretching device 10.    -   The internal control unit is preferably programmable from        outside the patient's body. In a preferred embodiment, the        internal control unit is programmed to regulate the stretching        device 10 to stretch the stomach according to a pre-programmed        time-schedule or to input from any sensor sensing any possible        physical parameter of the patient or any functional parameter of        the device.    -   In accordance with an alternative, the capacitor 60 in the        embodiment of FIG. 18 may be omitted. In accordance with another        alternative, the accumulator 58 in this embodiment may be        omitted.    -   FIG. 19 shows an embodiment of the invention identical to that        of FIG. 13 , except that a battery 70 for supplying energy for        the operation of the stretching device 10 and an electric switch        72 for switching the operation of the stretching device 10 also        is implanted in the patient. The electric switch 72 is operated        by the energy supplied by the implanted energy transforming        device 30 to switch from an off mode, in which the battery 70 is        not in use, to an on mode, in which the battery 70 supplies        energy for the operation of the stretching device 10.    -   FIG. 20 shows an embodiment of the invention identical to that        of FIG. 19 , except that an internal control unit 56        controllable by the wireless remote control of the external        energy transmission device 34 also is implanted in the patient.        In this case, the electric switch 72 is operated by the energy        supplied by the implanted energy transforming device 30 to        switch from an off mode, in which the wireless remote control is        prevented from controlling the internal control unit 56 and the        battery is not in use, to a standby mode, in which the remote        control is permitted to control the internal control unit 56 to        release electric energy from the battery 70 for the operation of        the stretching device 10.    -   FIG. 21 shows an embodiment of the invention identical to that        of FIG. 20 , except that an accumulator 58 is substituted for        the battery 70 and the implanted components are interconnected        differently. In this case, the accumulator 58 stores energy from        the implanted energy transforming device 30. In response to a        control signal from the wireless remote control of the external        energy transmission device 34, the internal control unit 56        controls the electric switch 72 to switch from an off mode, in        which the accumulator 58 is not in use, to an on mode, in which        the accumulator 58 supplies energy for the operation of the        stretching device 10.    -   FIG. 22 shows an embodiment of the invention identical to that        of FIG. 21 , except that a battery 70 also is implanted in the        patient and the implanted components are interconnected        differently. In response to a control signal from the wireless        remote control of the external energy transmission device 34,        the internal control unit 56 controls the accumulator 58 to        deliver energy for operating the electric switch 72 to switch        from an off mode, in which the battery 70 is not in use, to an        on mode, in which the battery 70 supplies electric energy for        the operation of the stretching device 10.    -   Alternatively, the electric switch 72 may be operated by energy        supplied by the accumulator 58 to switch from an off mode, in        which the wireless remote control is prevented from controlling        the battery 70 to supply electric energy and is not in use, to a        standby mode, in which the wireless remote control is permitted        to control the battery 70 to supply electric energy for the        operation of the stretching device 10.    -   It should be understood that the switch should be interpreted in        its broadest embodiment. This means an FPGA or a DA converter or        any other electronic component or circuit may switch power on        and off preferably being controlled from outside the body or by        an internal control unit.    -   FIG. 23 shows an embodiment of the invention identical to that        of FIG. 19 , except that a motor 40, a mechanical reversing        device in the form of a gear box 74, and an internal control        unit 56 for controlling the gear box 74 also is implanted in the        patient. The internal control unit 56 controls the gear box 74        to reverse the function performed by the stretching device 10        (mechanically operated). Even simpler is to switch the direction        of the motor electronically.    -   FIG. 24 shows an embodiment of the invention identical to that        of FIG. 22 except that the implanted components are        interconnected differently. Thus, in this case the internal        control unit 56 is powered by the battery 70 when the        accumulator 58, suitably a capacitor, activates the electric        switch 72 to switch to an on mode. When the electric switch 72        is in its on mode the internal control unit 56 is permitted to        control the battery 70 to supply, or not supply, energy for the        operation of the stretching device 10.    -   FIG. 25 schematically shows conceivable combinations of        implanted components of the device for achieving various        communication options. Basically, there are the stretching        device 10, the internal control unit 56, motor or pump unit 44,        and the external energy transmission device 34 including the        external wireless remote control. As already described above the        wireless remote control transmits a control signal which is        received by the internal control unit 56, which in turn controls        the various implanted components of the device.    -   A feedback device, preferably in the form of a sensor 76, may be        implanted in the patient for sensing a physical parameter of the        patient, such as a contraction wave in the esophagus 203        informing the patient is eating. The internal control unit 56,        or alternatively the external wireless remote control of the        external energy transmission device 34, may control the        stretching device 10 in response to signals from the sensor 76.        A transceiver may be combined with the sensor 76 for sending        information on the sensed physical parameter to the external        wireless remote control. The wireless remote control may        comprise a signal transmitter or transceiver and the internal        control unit 56 may comprise a signal receiver or transceiver.        Alternatively, the wireless remote control may comprise a signal        receiver or transceiver and the internal control unit 56 may        comprise a signal transmitter or transceiver. The above        transceivers, transmitters and receivers may be used for sending        information or data related to the stretching device 10 from        inside the patient's body to the outside thereof.    -   Alternatively, the sensor 76 may be arranged to sense a        functional parameter of the stretching device 10.    -   Where the motor/pump unit 44 and battery 70 for powering the        motor/pump unit 44 are implanted, the battery 70 may be equipped        with a transceiver for sending information on the condition of        the battery 70. To be more precise, when charging a battery or        accumulator with energy feedback information related to said        charging process is sent and the energy supply is changed        accordingly.    -   FIG. 26 shows an alternative embodiment wherein the stretching        device 10 is regulated from outside the patient's body. The        obesity treatment system 28 comprises a stretching device 10        connected to a battery 70 via a subcutaneous switch 80. Thus,        the regulation of the stretching device 10 is performed        non-invasively by manually pressing the subcutaneous switch,        whereby the operation of the stretching device 10 is switched on        and off. It will be appreciated that the shown embodiment is a        simplification and that additional components, such as an        internal control unit or any other part disclosed in the present        application can be added to the obesity treatment system.    -   FIG. 27 shows an alternative embodiment, wherein the obesity        treatment system 28 comprises a stretching device 10 in fluid        connection with a hydraulic fluid reservoir 52. Non-invasive        regulation is performed by manually pressing the hydraulic        reservoir connected to the stretching device 10.    -   A further embodiment of a system according to the invention        comprises a feedback device for sending information from inside        the patient's body to the outside thereof to give feedback        information related to at least one functional parameter of the        stretching device or system or a physical parameter of the        patient, thereby optimizing the performance of the system.    -   One preferred functional parameter of the device is correlated        to the transfer of energy for charging the internal energy        source.    -   In FIG. 28 , an arrangement is schematically illustrated for        supplying an accurate amount of energy to a obesity treatment        system 28 implanted in a patient, whose skin 36 is indicated by        a vertical line. A stretching device 10 is connected to an        implanted energy transforming device 30, likewise located inside        the patient, preferably just beneath the patient's skin 36.        Generally speaking, the implanted energy transforming device 30        may be placed in the abdomen, thorax, muscle fascia (e.g. in the        abdominal wall), subcutaneously, or at any other suitable        location. The implanted energy transforming device 30 is adapted        to receive wireless energy E transmitted from an external energy        source 34 a provided in the external energy transmission device        34 located outside the patient's skin 36 in the vicinity of the        implanted energy transforming device 30.    -   As is well known in the art, the wireless energy E may generally        be transferred by means of any suitable Transcutaneous Energy        Transfer (TET) device, such as a device including a primary coil        arranged in the external energy source 34 a and an adjacent        secondary coil arranged in the implanted energy transforming        device 30. When an electric current is fed through the primary        coil, energy in the form of a voltage is induced in the        secondary coil which can be used to operate a stretching device,        e.g. after storing the incoming energy in an energy storing        device or accumulator, such as a battery or a capacitor.        However, the present invention is generally not limited to any        particular energy transfer technique, TET devices or energy        storing devices, and any kind of wireless energy may be used.    -   The amount of energy received inside the body to the device may        be compared with the energy used by the device. The term used by        the device is then understood to include also energy stored by        the device. The amount of transferred energy can be regulated by        means of an external control unit 34 b controlling the external        energy source 34 a based on the determined energy balance, as        described above. In order to transfer the correct amount of        energy, the energy balance and the required amount of energy can        be determined by means of an internal control unit 56 connected        to the stretching device 10. The internal control unit 56 may        thus be arranged to receive various measurements obtained by        suitable sensors or the like, not shown, measuring certain        characteristics of the stretching device 10, somehow reflecting        the required amount of energy needed for proper operation of the        stretching device 10. Moreover, the current condition of the        patient may also be detected by means of suitable measuring        devices or sensors, in order to provide parameters reflecting        the patient's condition. Hence, such characteristics and/or        parameters may be related to the current state of the stretching        device 10, such as power consumption, operational mode and        temperature, as well as the patient's condition reflected by,        e.g., body temperature, blood pressure, heartbeats and        breathing.    -   Furthermore, an energy storing device or accumulator 58 may        optionally be connected to the implanted energy transforming        device 30 for accumulating received energy for later use by the        stretching device 10. Alternatively or additionally,        characteristics of such an accumulator, also reflecting the        required amount of energy, may be measured as well. The        accumulator may be replaced by a battery, and the measured        characteristics may be related to the current state of the        battery, such as voltage, temperature, etc. In order to provide        sufficient voltage and current to the stretching device 10, and        also to avoid excessive heating, it is clearly understood that        the battery should be charged optimally by receiving a correct        amount of energy from the implanted energy transforming device        30, i.e. not too little or too much. The accumulator may also be        a capacitor with corresponding characteristics.    -   For example, battery characteristics may be measured on a        regular basis to determine the current state of the battery,        which then may be stored as state information in a suitable        storage means in the internal control unit 56. Thus, whenever        new measurements are made, the stored battery state information        can be updated accordingly. In this way, the state of the        battery can be “calibrated” by transferring a correct amount of        energy, so as to maintain the battery in an optimal condition.    -   Thus, the internal control unit 56 is adapted to determine the        energy balance and/or the currently required amount of energy,        (either energy per time unit or accumulated energy) based on        measurements made by the above-mentioned sensors or measuring        devices on the stretching device 10, or the patient, or an        energy storing device if used, or any combination thereof. The        internal control unit 56 is further connected to an internal        signal transmitter 82, arranged to transmit a control signal        reflecting the determined required amount of energy, to an        external signal receiver 34 c connected to the external control        unit 34 b. The amount of energy transmitted from the external        energy source 34 a may then be regulated in response to the        received control signal.    -   Alternatively, sensor measurements can be transmitted directly        to the external control unit 34 b wherein the energy balance        and/or the currently required amount of energy can be determined        by the external control unit 34 b, thus integrating the        above-described function of the internal control unit 56 in the        external control unit 34 b. In that case, the internal control        unit 56 can be omitted and the sensor measurements are supplied        directly to the internal signal transmitter 82 which sends the        measurements over to the external signal receiver 34 c and the        external control unit 34 b. The energy balance and the currently        required amount of energy can then be determined by the external        control unit 34 b based on those sensor measurements.    -   Hence, the present solution employs the feedback of information        indicating the required energy, which is more efficient than        previous solutions because it is based on the actual use of        energy that is compared to the received energy, e.g. with        respect to the amount of energy, the energy difference, or the        energy receiving rate as compared to the energy rate used by the        stretching device. The stretching device may use the received        energy either for consuming or for storing the energy in an        energy storage device or the like. The different parameters        discussed above would thus be used if relevant and needed and        then as a tool for determining the actual energy balance.        However, such parameters may also be needed per se for any        actions taken internally to specifically operate the stretching        device.    -   The internal signal transmitter 82 and the external signal        receiver 34 c may be implemented as separate units using        suitable signal transfer means, such as radio, IR (Infrared) or        ultrasonic signals. Alternatively, the internal signal        transmitter 82 and the external signal receiver 34 c may be        integrated in the implanted energy transforming device 30 and        the external energy source 34 a, respectively, so as to convey        control signals in a reverse direction relative to the energy        transfer, basically using the same transmission technique. The        control signals may be modulated with respect to frequency,        phase or amplitude.    -   To conclude, the energy supply arrangement illustrated in FIG.        28 may operate basically in the following manner. The energy        balance is first determined by the internal control unit 56. A        control signal reflecting the required amount of energy is also        created by the internal control unit 56, and the control signal        is transmitted from the internal signal transmitter 82 to the        external signal receiver 34 c. Alternatively, the energy balance        can be determined by the external control unit 34 b instead        depending on the implementation, as mentioned above. In that        case, the control signal may carry measurement results from        various sensors. The amount of energy emitted from the external        energy source 34 a can then be regulated by the external control        unit 34 b, based on the determined energy balance, e.g. in        response to the received control signal. This process may be        repeated intermittently at certain intervals during ongoing        energy transfer, or may be executed on a more or less continuous        basis during the energy transfer.    -   The amount of transferred energy can generally be regulated by        adjusting various transmission parameters in the external energy        source 34 a, such as voltage, current, amplitude, wave frequency        and pulse characteristics.    -   A method is thus provided for controlling transmission of        wireless energy supplied to an electrically operable stretching        device implanted in a patient. The wireless energy E is        transmitted from an external energy source located outside the        patient and is received by an internal energy receiver located        inside the patient, the internal energy receiver being connected        to the stretching device for directly or indirectly supplying        received energy thereto. An energy balance is determined between        the energy received by the internal energy receiver and the        energy used for the stretching device. The transmission of        wireless energy E from the external energy source is then        controlled based on the determined energy balance.    -   A system is also provided for controlling transmission of        wireless energy supplied to an electrically operable stretching        device implanted in a patient. The system is adapted to transmit        the wireless energy E from an external energy source located        outside the patient which is received by an implanted energy        transforming device located inside the patient, the implanted        energy transforming device being connected to the stretching        device for directly or indirectly supplying received energy        thereto. The system is further adapted to determine an energy        balance between the energy received by the implanted energy        transforming device and the energy used for the stretching        device, and control the transmission of wireless energy E from        the external energy source, based on the determined energy        balance.    -   The functional parameter of the device is correlated to the        transfer of energy for charging the internal energy source.    -   In yet an alternative embodiment, the external source of energy        is controlled from outside the patient's body to release        electromagnetic wireless energy, and released electromagnetic        wireless energy is used for operating the stretching device.    -   In another embodiment, the external source of energy is        controlling from outside the patient's body to release        non-magnetic wireless energy, and released non-magnetic wireless        energy is used for operating the stretching device.    -   Those skilled in the art will realize that the above various        embodiments according to FIGS. 17-29 could be combined in many        different ways. For example, the electric switch 38 operated by        polarized energy could be incorporated in any of the embodiments        of FIGS. 11, 18-24 , the hydraulic valve shifting device 54        could be incorporated in the embodiment of FIG. 16 , and the        gear box 74 could be incorporated in the embodiment of FIG. 15 .        Please observe that the switch simply could mean any electronic        circuit or component.    -   Wireless transfer of energy for operating the stretching device        has been described to enable non-invasive operation. It will be        appreciated that the stretching device can be operated with wire        bound energy as well. One such example is shown in FIG. 29 ,        wherein an external switch 84 is interconnected between the        external energy source 34 a and an operation device, such as an        electric motor regulating the stretching device 10, by means of        power lines 86 and 88. An external control unit 34 b controls        the operation of the external switch to effect proper operation        of the stretching device 10.

Hydraulic or Pneumatic Powering

-   -   FIGS. 30-33 show in more detail block diagrams of four different        ways of hydraulically or pneumatically powering a device for        treating obesity according to the invention.    -   FIG. 30 shows a device for treating obesity as described above        with reference to any of FIGS. 1-6 . The device comprises a        stretching device 10 and further a separate regulation reservoir        16, a one way pump 44 and an alternate valve 54.    -   FIG. 31 shows the stretching device 10 and a fluid reservoir 16.        By moving the wall of the regulation reservoir or changing the        size of the same in any other different way, the adjustment of        the stretching device may be performed without any valve, just        free passage of fluid any time by moving the reservoir wall.    -   FIG. 32 shows the stretching device 10, a two way pump 44 and        the regulation reservoir 16.    -   FIG. 33 shows a block diagram of a reversed servo system with a        first closed system controlling a second closed system. The        servo system comprises a regulation reservoir 16 and a servo        reservoir 90. The servo reservoir 90 mechanically controls a        stretching device 10 via a mechanical interconnection 94, the        stretching device having an expandable/contactable cavity. This        cavity is preferably expanded or contracted by supplying        hydraulic fluid from the larger adjustable reservoir 92 in fluid        connection with the stretching device 10. Alternatively, the        cavity contains compressible gas, which can be compressed and        expanded under the control of the servo reservoir 90.    -   The servo reservoir 90 can also be part of the stretching device        itself    -   In one embodiment, the regulation reservoir is placed        subcutaneous under the patient's skin 36 and is operated by        pushing the outer surface thereof by means of a finger. This        obesity treatment system is illustrated in FIGS. 34 a-c . In        FIG. 34 a , a flexible subcutaneous regulation reservoir 16 is        shown connected to a bulge shaped servo reservoir 90 by means of        a conduit 18. This bellow shaped servo reservoir 90 is comprised        in a flexible stretching device 10. In the state shown in FIG.        34 a , the servo reservoir 90 contains a minimum of fluid and        most fluid is found in the regulation reservoir 16. Due to the        mechanical interconnection between the servo reservoir 90 and        the stretching device 10, the outer shape of the stretching        device 10 is contracted, i.e., it occupies less than its maximum        volume. This maximum volume is shown with dashed lines in the        figure.    -   FIG. 34 b shows a state wherein a user, such as the patient in        with the stretching device is implanted, presses the regulation        reservoir 16 so that fluid contained therein is brought to flow        through the conduit 18 and into the servo reservoir 90, which,        thanks to its bellow shape, expands longitudinally. This        expansion in turn expands the stretching device 10 so that it        occupies its maximum volume, thereby stretching the stomach wall        (not shown) which it contacts.    -   The regulation reservoir 16 is preferably provided with means        for keeping its shape after compression. This means, which is        schematically shown as 16 a in the figure, will thus keep the        stretching device 10 in a stretched position also when the user        releases the regulation reservoir. In this way, the regulation        reservoir essentially operates as an on/off switch for the        obesity treatment system.    -   An alternative embodiment of hydraulic or pneumatic operation        will now be described with reference to FIGS. 35 and 36 a-c. The        block diagram shown in FIG. 35 comprises with a first closed        system controlling a second closed system. The first system        comprises a regulation reservoir 16 and a servo reservoir 90.        The servo reservoir 90 mechanically controls a larger adjustable        reservoir 92 via a mechanical interconnection 94. A stretching        device 10 having an expandable/contactable cavity is in turn        controlled by the larger adjustable reservoir 92 by supply of        hydraulic fluid from the larger adjustable reservoir 92 in fluid        connection with the stretching device 10.    -   An example of this embodiment will now be described with        reference to FIG. 36 a-c . Like in the previous embodiment, the        regulation reservoir is placed subcutaneous under the patient's        skin and is operated by pushing the outer surface thereof by        means of a finger. The regulation reservoir 16 is in fluid        connection with a bellow shaped servo reservoir 90 by means of a        conduit 18. In the first closed system 16, 18, 90 shown in FIG.        34 a , the servo reservoir 90 contains a minimum of fluid and        most fluid is found in the regulation reservoir 16.    -   The servo reservoir 90 is mechanically connected to a larger        adjustable reservoir 92, in this example also having a bellow        shape but with a larger diameter than the servo reservoir 90.        The larger adjustable reservoir 92 is in fluid connection with        the stretching device 10. This means that when a user pushes the        regulation reservoir 16, thereby displacing fluid from the        regulation reservoir 16 to the servo reservoir 90, the expansion        of the servo reservoir 90 will displace a larger volume of fluid        from the larger adjustable reservoir 92 to the stretching device        10. In other words, in this reversed servo, a small volume in        the regulation reservoir is compressed with a higher force and        this creates a movement of a larger total area with less force        per area unit.    -   Like in the previous embodiment described above with reference        to FIGS. 34 a-c , the regulation reservoir 16 is preferably        provided with means for keeping its shape after compression.        This means, which is schematically shown as 16 a in the figure,        will thus keep the stretching device 10 in a stretched position        also when the user releases the regulation reservoir. In this        way, the regulation reservoir essentially operates as an on/off        switch for the obesity treatment system.

Method

-   -   A method for surgically treating an obese patient, the method        comprising the steps of cutting an opening in the abdominal wall        of the patient, dissecting an area around the stomach, placing a        device for treating to a part of the stomach wall of the        patient, and suturing the stomach wall.    -   The device for treating obesity is preferably placed in a        patient via a laparoscopic abdominal approach, comprising the        steps of: inserting a needle or a tube like instrument into the        abdomen of the patient's body, using the needle or a tube like        instrument to fill the patient's abdomen with gas thereby        expanding the patient's abdominal cavity, placing at least two        laparoscopic trocars in the patient's body, inserting a camera        through one of the laparoscopic trocars into the patient's        abdomen, inserting at least one dissecting tool through one of        said at least two laparoscopic trocars and dissecting an        intended placement area of the patient, and placing a device for        treating obesity in connection with the stomach wall.

The methods could further comprise the step of postoperativelyregulating the at least one stretching device to: stretch a part of thestomach wall and regulate the stretching device from outside thepatient's body to affect the appetite of the patient.

Instruments

-   -   An intraluminar method of invaginating a stretching device 10 on        the outside of the stomach wall 12 will now be described with        reference to FIGS. 5 a-i . Initially, an instrument 600,        preferably a gastroscopic instrument, is inserted into the mouth        of the patient, see FIG. 5 a . The instrument comprises an        injection device 601, 602 for injecting either fluid or a device        into the stomach of the patient. The instrument 600 further        comprises a control unit 606 adapted for controlling the        operation of the instrument. To this end, the control unit 606        comprises one or more steering devices, in the embodiment shown        in the figure in the form of two joysticks 603 and two control        buttons 604. A display 605 is provided for displaying the image        provided by an optical device for viewing inside the stomach,        such as a camera (not shown) arranged at the outer end of the        elongated member 607, see FIGS. 5 e-i . The camera, which may        comprise connecting electrical wires extending along the        elongated member, may be assisted by a light source (not shown)        placed distally on the elongated member for illuminating the        inside of the stomach. The optical device may also comprise        optical fibers placed along the elongated member and leading out        from the patient's body for external viewing of the inside of        the stomach.    -   The instrument is further inserted into the esophagus and into        the stomach of the patient, sees FIG. 37 b . By means of the        instrument 600, a hole 12 b is created in the wall of the        stomach 12. To this end, the instrument is provided with one or        more cutters 615 at the distal end thereof. These cutters can of        course be designed in different ways, such as a toothed drum        cutter rotating about the center axis of the tube-like        instrument.    -   After cutting a hole in the stomach wall, the distal end of the        instrument 600 is inserted into and through the hole 2 b so that        it ends up outside the stomach wall 12 a. This is shown in FIG.        37 c , showing a side view of the stomach 12, and FIG. 37 d ,        which is a sectional view through the stomach of FIG. 37 c taken        along the lines Vd−Vd.    -   The instrument 600 is adapted to create a “cavity” or “pouch” on        the outside of the stomach around the hole 12 b in the stomach        wall 12. Such an instrument and the method of providing the        pouch will now be described.    -   FIGS. 37 e-i show a gastroscopic or laparoscopic instrument for        invaginating a stretching device 10 in the stomach wall 12 of        the patient by creating a pouch of stomach wall 12 material in        which the stretching device 10 is placed. The instrument,        generally designated 600, and which may comprise the features        described above with reference to FIGS. 4 a-d , comprises an        elongated member 607 having a proximal end and a distal end, the        elongated member 607 having a diameter less than that of the        patient's esophagus and being flexible such as to allow        introduction of the flexible elongated member 607 with its        distal end first through the patient's throat, esophagus and        into the stomach 12 to the stomach wall 12 a.    -   The stomach penetration device or cutter 615 is provided on the        elongated member 607 at the distal en thereof for penetrating        the stomach wall 12 a so as to create a hole in the stomach wall        12 a, to allow introduction of the elongated member 607 through        the hole. The stomach penetration device 615 could be adapted to        be operable for retracting said stomach penetration device 615        after the stomach fundus wall 12 a has been penetrated, for not        further damaging tissue within the body. The instrument further        comprises a special holding device 609 provided on the elongated        member 607 on the proximal side to the penetration device 615.    -   The elongated member further comprises an expandable member 611        which is adapted to be expanded after the elongated member has        penetrated the stomach wall 12 a and thereby assist in the        creation of a cavity or pouch adapted to hold the volume filling        device 610. The expandable member 611 may comprise an inflatable        circular balloon provided circumferentially around the distal        end portion of the flexible elongated member 607.    -   The method steps when invaginating the volume filling device        will now be described in detail. After the instrument 600 has        been inserted into the stomach 12, the stomach penetration        device 615 is placed into contact with the stomach wall 12, see        FIG. 37 e . The stomach penetration device or cutter 615 is then        brought to create the hole 12 b in the stomach wall, whereafter        at least the expandable member 611 is brought through the hole        12 b in the stomach wall. The special holding device 609 is in        this step brought to a holding state wherein it expands radially        so as to form an essentially circular abutment surface to the        stomach wall 12, see FIG. 37 f . In this way, the insertion of        the stomach penetration device 615 and the expandable member 611        through the hole 12 in the stomach wall is limited to the        position shown in FIG. 37 f.    -   The expandable member 611 is then expanded. In the case the        expandable member comprises a balloon or the like, air or other        fluid is injected into it.    -   The part of the elongated member 607 comprising the expandable        member 611 is then retracted in the proximal direction, as        indicated by the arrow in FIG. 37 g , thereby pulling the        stomach wall 612 into a basket or cup like structure created by        the special holding device 609.    -   A suturing or stapling device 608 is further provided, either as        a device connected to the elongated member 607 or as a separate        instrument. The suturing or stapling member comprises a suturing        or stapling end 613 which is adapted to close the cavity or        pouch by means of stomach to stomach sutures or staples 14.    -   In a further step, illustrated in FIG. 37 h , an inflatable        stretching device 10 is placed in its deflated state in the cup        like structure. The stretching device 10 is then inflated to its        inflated or expanded state, see FIG. 37 i . This inflation of        the stretching device 10 can be accomplished by injecting a        fluid or a gel into the deflated stretching device. It can also        be accomplished by injecting a material which is allowed to        cure, thereby forming a solid device 10. Thus, the stretching        device 10 shown in FIGS. 37 h and 37 i can illustrate either a        balloon-like device which is subsequently filled with fluid or        gel or alternatively a material which is simply injected into        the cup like structure formed by the stomach wall 12.    -   The fluid which is used to fill the stretching device 10 could        be any suitable fluid suitable to fill the stretching device 10,        such as a salt solution. In another embodiment, when this fluid        is a fluid which is adapted to be transformed into solid state,        the fluid could be liquid polyurethane.    -   In order to minimize or entirely eliminate leakage, the fluid is        iso-tonic, i.e., it has the same osmolarity as human body        fluids. Another way of preventing diffusion is to provide a        fluid which comprises large molecules, such as iodine molecules.    -   The stomach-to-stomach sutures or staples 14 are preferably        provided with fixation portions exhibiting a structure, such as        a net like structure, adapted to be in contact with the stomach        wall 12 to promote growth in of human tissue to secure the long        term placement of the stretching device attached to the stomach        wall.    -   Thereby is the inflatable stretching device 10 in its inflated        or expanded state invaginated by a stomach wall portion of the        patient on the outside of the stomach wall 12.    -   During one or more of the above described steps, the stomach may        be inflated with gas, preferably by means of the gastroscopic        instrument.    -   The stretching device 10 described above with reference to FIGS.        37 a-i has been described as an inflatable stretching device. It        will be appreciated that it also can be an elastic stretching        device with an elasticity allowing compression so as to be        inserted into a gastroscopic instrument and which expands to an        expanded state after leaving the instrument.    -   In one embodiment, the stretching device 10 comprises an        inflatable stretching device 10 expandable to an expanded state.        In this case, the inflatable stretching device 10 is provided        with an inlet port 18 b for a fluid and is adapted to be        connected to a gastroscopic instrument. This embodiment will now        be described in detail with reference to FIGS. 38 a -38 d.    -   An inflatable stretching device in its non-expanded state is        shown in FIG. 38 a . It is essentially a balloon-like, deflated        stretching device 10 having an inlet port 18 b. In this state,        the inflatable stretching device 10 has a diameter of a few        millimeters at the most, allowing it to be inserted into the        stomach through the esophagus of the patient by means of a        gastroscopic, tube-like instrument 600, or through a        laparoscopic trocar in an abdominal laparoscopic method using a        tube like instrument 600 depicted in FIG. 38 b . The instrument        comprises an outer sleeve 600 a and an inner sleeve 600 b which        can be displaced longitudinally relatively to the outer sleeve.        The inner sleeve is provided with a cutter in the form of a        cutting edge 615 at the distal end thereof. This cutting edge        can be used for cutting a hole in the stomach wall, as will be        explained in detail in the following.    -   When the instrument reaches a stomach wall, from the inside or        outside thereof, see FIG. 38 c , the inner sleeve is brought        forward from its position in the outer sleeve and into contact        with the stomach wall 12 a. The cutting edge 615 of the inner        sleeve then cuts a hole in the stomach wall so as to allow        subsequent insertion of the volume filling device 10 into and        through this hole, see FIG. 38 d . In order to push the        stretching device through the hole, a piston 602 may be provided        in the instrument. Thus, the instrument further comprises a        piston 602 adapted for pushing a deflated stretching device 10        out from a position in the inner sleeve, this position being        shown in FIG. 38 b , to a position outside of the inner sleeve,        this being shown in FIG. 38 d.    -   In order to protect the deflated stretching device 10 from the        cutting edge 615 of the inner sleeve, a further protective        sleeve (not shown) can be provided around the stretching device.    -   FIG. 39 a-j shows an instrument for use in a method of engaging        a stretching device 10 to the stomach wall 12 of a patient. The        instrument is adapted to be inserted through a narrow tube        shaped object such as a gastroscope, used in an intraluminar        procedure, or a laparoscopic trocar used in a laparoscopic        procedure. The instrument comprises an elongated member 650        which is adapted to be flexible by means of a construction        comprising multiple ring shaped members, however it is equally        conceivable that said elongated member 650 is adapted to be        flexible by means of said elongated member 650 being made of a        flexible or adjustable material. The elongated member 650 is        inserted into the body and placed in proximity to the stomach        wall 12 of the patient, from the outside or inside thereof. The        elongated member 650 has a special holding device 651 adapted to        hold the stomach by means of mechanical grabbing members or        vacuum. The special holding device 651 comprises a first joint        652 and a second joint 653, which enables the special holding        device 651 be operable in relation to the elongated member 650        and thereby place the part of the holding device 651 comprising        the mechanical grabbing members or vacuum elements in contact        with the stomach wall 12 of the patient. FIG. 39 b shows the        special holding device 651 when placed in contact with the        stomach wall 12 of the human patient, after which the special        holding member 651 connects to the stomach wall 12, for holding        the stomach wall 12. FIG. 39 c shows the instrument when the        step of advancing a pushing rod 654 from the elongated member        650 is performed. The pushing rod 654 pushes the stomach wall 12        to create a cavity or pouch thereof. FIG. 39 d shows the        instrument turned 90° in relation to FIGS. 39 a-c . This view        shows the special holding members 651 a,b operably attached to        two sides of the elongated member 650 and being in contact with        the stomach wall 12, holding the stomach wall 12 as the pushing        rod 654 pushes to create a cavity or pouch. When the pushing rod        654 has pushed the stomach wall 12 to a desired position the        special holding devices 651 a,b moves towards the pushing rod        654 and thereby closes the cavity or pouch.    -   After the cavity or pouch has been created it needs to be        sealed. FIG. 39 f shows the advancement of a suturing or        stapling device 655 from the elongated member 650. The suturing        or stapling device 655 is positioned in connection with the        stomach wall after which the suturing or stapling device        commences with the suturing or stapling of the stomach wall 12,        creating a seal of stomach to stomach sutures or staplers 14.        The instrument is moved along the stomach wall 12 of the patient        and thereby a cavity or pouch is created and sealed using the        instrument, as shown in FIGS. 39 g and 39 h . When a cavity or        pouch or desired size has been created and sealed an inserting        member 656 is advanced from the elongated member 650. The        inserting member 656 is adapted to insert a stretching device 10        being inflatable, as described earlier in this application.        After the inserting member 656 has been positioned in the cavity        or pouch the stretching device 10 is inserted through the        inserting member 656 and into the cavity or pouch by means of a        pressurized fluid or gas, or a mechanical advancement member        pushing said inflatable stretching device 10 into the cavity or        pouch. The insertion member then inflates the inflatable        stretching device with a fluid or gas and seals of the final        section of the pouch using stomach to stomach sutures or        staplers 14. The embodiment described explains the process of        inserting an inflatable stretching device, however it is equally        conceivable that the stretching device 10 is expandable by means        of the stretching device 10 being made of an elastic material.    -   FIG. 40 a-f shows an instrument for use in a method of engaging        a stretching device 10 to the stomach wall 12 of a patient. The        instrument is adapted to be inserted through a narrow tube        shaped object such as a gastroscope, used in an intraluminar        procedure, or a laparoscopic trocar used in a laparoscopic        procedure. The instrument comprises an elongated member 660        which is adapted to be flexible by means of a construction        comprising multiple ring shaped members, however it is equally        conceivable that said elongated member 660 is adapted to be        flexible by means of said elongated member 660 being made of a        flexible or adjustable material. The elongated member 660 is        inserted into the body and placed in proximity to the stomach        wall 12 of the patient, from the outside or inside thereof. The        elongated member 660 has multiple special holding devices 661        adapted to hold the stomach by means of mechanical grabbing        members or vacuum. The special holding devices 661 are locked in        a position alongside the elongated member 660 by means of a        locking ring 662. The special holding devices are made of a        flexible material end pre-bent to expand into a funnel-shaped        device when said locking ring 662 is removed. The special        holding device in its funnel shaped expandable state is shown in        FIG. 40 b . FIG. 40 b further shows the special holding device        661 when placed in contact with the stomach wall 12 of the human        patient, after which the special holding member 661 connects to        the stomach wall 12, for holding the stomach wall 12. FIG. 40 c        shows the instrument when the step of advancing a pushing rod        664 from the elongated member 660 is performed. The pushing rod        664 pushes the stomach wall 12 to create a cavity or pouch        thereof. When the pushing rod 664 has pushed the stomach wall 12        to a desired position the special holding devices 661 moves        towards the pushing rod 664 and thereby closes the cavity or        pouch.    -   After the cavity or pouch has been created it needs to be        sealed. FIG. 40 d shows the advancement of a suturing or        stapling device 665 from the elongated member 660. The suturing        or stapling device 665 is positioned in connection with the        stomach wall 12 after which the suturing or stapling device 665        commences with the suturing or stapling of the stomach wall 12,        creating a seal of stomach to stomach sutures or staplers 14.        Thereafter an inserting member 666 is advanced from the        elongated member 660 and the special holding devices 661 are        retracted. The inserting member 666 is adapted to insert a        stretching device 10 being inflatable, as described earlier in        this application. After the inserting member 666 has been        positioned in the cavity or pouch the stretching device 10 is        inserted through the inserting member 666 and into the cavity or        pouch by means of a pressurized fluid or gas, or a mechanical        advancement member pushing said inflatable stretching device 10        into the cavity or pouch. The insertion member 656 then inflates        the inflatable stretching device with a fluid or gas and seals        of the final section of the pouch using stomach to stomach        sutures or staplers 14. The embodiment described explains the        process of inserting an inflatable stretching device 10, however        it is equally conceivable that the stretching device 10 is        expandable by means of the stretching device 10 being made of an        elastic material. FIG. 40 f shows the stretching device 10 as        the stretching device 10 is invaginated in the stomach wall 12,        in a cavity or pouch sealed with stomach to stomach sutures or        staplers 14.    -   FIG. 41 a shows an instrument used in a method of engaging the        stretching device according to any of the embodiments of the        application to the stomach wall 12. The instrument comprises an        elongated member 670 which is adapted to be flexible by means of        a construction comprising multiple ring shaped members, however        it is equally conceivable that said elongated member 670 is        adapted to be flexible by means of said elongated member 670        being made of a flexible or adjustable material. The elongated        member 670 is inserted into the body and placed in proximity to        the stomach wall 12 of the patient, from the inside thereof. A        stomach penetrating member 672 is placed in the distal end of        the elongated member 670, retractably fixated to a protective        sleeve 673 adapted to protect the tissue of the body from the        sharp penetrating member 672 or cutter 672 after the cutting        operation has been performed.    -   FIG. 41 b shows the instrument comprising the elongated member        670 after the cutting operation has been performed and the        stomach penetrating member or cutter 672 has been retracted into        the protective sleeve 673. A guiding wire 671 is pushed through        the elongated member 670, through the hole made in the stomach        wall 12 and out through the abdomen and placed on the inside of        the patients skin, which is penetrated from the outside to        enable the guiding wire 671 to exit the abdomen. The guiding        wire 671 can then be used to guide a conduit 18 or a lead        attached to the stretching device 10 being placed in the stomach        from the inside thereof. The stretching device 10 with the        conduit 18 or electrical lead being a stretching device 10        according to any of the embodiments of this application. The        guiding of the conduit 18 or electrical lead enables the        attachment of the conduit 18 or electrical lead to a control        unit 42 placed subcutaneously in the patient from the outside of        the abdomen.    -   FIG. 42 shows a flowchart describing the steps needed in an        intraluminar method of inserting a device for stretching a        portion of the stomach wall, the method comprises the steps of        inserting an instrument into the esophagus 203 of the patient,        step 1 a, inserting a device into the stomach of the patient        through the esophagus 203 using the instrument, step 2 a,        placing the device 10 in contact with the stomach wall 12, step        3 a, fixating the device to the stomach wall 12 such that the        device can stretch a part of the stomach wall 12. The method        described could further comprise the step of non-invasively        regulating the device after the placing of the device has been        completed.    -   FIG. 43 shows a flowchart describing the steps needed in an        abdominal method of inserting a device for stretching a portion        of the stomach wall, the method comprises the steps of cutting a        hole in the abdominal wall of said patient, step 1 b, dissecting        an area around the stomach, step 2 b, placing said device in        contact with the stomach, step 3 b and fixating direct or        indirect through invagination of the stomach wall the device to        the stomach wall such that the device can stretch a portion of        said stomach wall, step 4 b. The method described could further        comprise the steps of closing the hole in the abdomen using        sutures or staplers 14 and non-invasively regulating the device        after the placing of the device has been completed.

The invention claimed is:
 1. An apparatus for treating obesity of anobese patient having a stomach with a food cavity, the apparatuscomprising: at least one operable stretching device implantable in thepatient operating to stretch a portion of the patient's stomach wall,the at least one operable stretching device comprising at least twooperable stretching devices, a first operable stretching device and asecond operable stretching device, and an implantable control unit forautomatically controlling the operable stretching device, when thecontrol unit and stretching device are implanted, to stretch the stomachwall portion in connection with the patient eating such that satiety iscreated, wherein the implantable control unit is adapted to control a)the first operable stretching device, during a first time period, tostretch a first portion of the stomach wall, and b) the second operablestretching device, during a second time period, to stretch a secondportion of the stomach wall different from said first portion of thestomach, to allow longer relaxation of the stomach wall in betweenstretching periods.
 2. The apparatus according to claim 1, furthercomprising an operation device for operating the at least one operablestretching device, wherein the control unit controls the operationdevice to stretch the stomach wall portion, when the implantable controlunit and the at least one operable stretching device are implanted. 3.The apparatus according to claim 1, further comprising a sensing deviceincluding a sensor for sensing a physical parameter of the patient or afunctional parameter of the stretching device, wherein the sensingdevice sends information relating to the parameter to the control unit,and the control unit controls the stretching device based on theinformation.
 4. The apparatus according to claim 1, wherein theimplantable control unit is adapted to control the stretching device tointermittently stretch the stomach wall, when the control unit andstretching device are implanted.
 5. The apparatus according to claim 1,wherein the implantable control unit is adapted to control the amount ofstretching performed by the stretching device on the stomach wall. 6.The apparatus according to anyone of claim 5, wherein the control unitcontrols the stretching device to vary over time the amount ofstretching of the stomach wall.
 7. The apparatus according to claim 1,wherein the implantable control unit is adapted to control thestretching device to stretch the stomach wall during a predeterminedtime period.
 8. The apparatus according to claim 1, wherein theimplantable control unit is adapted to control the stretching devicebased on the patient's food intake.
 9. The apparatus according to claim1, wherein the implantable control unit is programmable to include anyof: a) predetermined time period during which the stretching device iscontrolled to stretch the stomach wall, and b) the magnitude ofstretching applied on the stomach wall.
 10. The apparatus according toclaim 2, wherein the operation device is a mechanical operation device.11. The apparatus according to claim 2, wherein the operation device isa hydraulic operation device.
 12. The apparatus according to claim 2,wherein the operation device is a hydraulically operated mechanicaloperation device.
 13. The apparatus according to claim 2, wherein theoperation device is a mechanically operated hydraulic operation device.14. The apparatus according to claim 3, wherein the sensor of thesensing device senses the patient's food intake directly or indirectly,and the implantable control unit controls the operation device tostretch the stomach wall in response to signals from the sensor.
 15. Theapparatus according to claim 1, wherein the implantable control unit isadapted to control the operation device to stretch the stomach wallusing more than one operable stretching device.
 16. The apparatusaccording to claim 14, wherein the sensor of the sensing device isadapted to sense a parameter related to the patient's food intake. 17.The apparatus according to claim 16, wherein the parameter is one ofesophagus movement, esophagus bending, esophagus motility, esophagusstretching, esophagus pressure, food passing esophagus, food in thestomach, neural activity, vagus activity, muscle activity, hormonalactivity, stomach motility, stomach stretching, stomach pressure,stomach bending, stomach filling, and acidity in the stomach.
 18. Theapparatus according to claim 1, comprising three or more operablestretching devices.